Search report for vigilance / recall

Clinical evaluation template

Search report for vigilance / recall for medical device clinical evaluation

Use this editable Search report for vigilance / recall to structure clinical evidence, justify safety and performance conclusions, and keep your MDR/IVDR clinical evaluation documentation audit-ready.

Structure clinical evidenceCollect, appraise and analyse data with a repeatable methodology.

Align with MDCG 2020-6Rank and weight clinical data according to EU guidance.

Support notified-body reviewTrace decisions from evidence to GSPR conclusions.

Best for: clinical evaluation planning, CER/CEP/SSCP preparation, PMCF evidence review and literature appraisal.
Includes: editable sections aligned with MDR Annex XIV, MDCG 2020-6 and relevant MEDDEV guidance.
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At Lexqara, we connect clinical documentation, PMS activities and regulatory strategy so manufacturers can build defensible clinical evidence packages. Explore the Resource Center, review our Clinical Evaluation Services, or consult MDCG 2020-6 for the clinical evidence hierarchy.

Description:
This Vigilance and Recall Search Report provides a clear, audit-ready record of how we search public vigilance and recall databases to identify clinical risks. It covers device problems and patient problems linked to the subject device, equivalent device, and similar devices, supporting Safety & Performance (S&P) and S&P acceptance criteria (S&P AC) decisions.

Confirm the search follows the approved protocol and document any deviations with a justified impact assessment.
Record the responsible person and the implementation date for every database search.
Define and justify the search period (start date and end date) to ensure evidence is current and relevant.
Search predefined vigilance and recall databases (e.g., FDA MAUDE, FDA Medical Device Recalls, ANSM, BfArM, MHRA, Swissmedic, DAEN, SARA, Canadian Recalls and Safety Alerts) and justify why each source is relevant to your device and markets.
Apply a consistent search limitation strategy when filters differ between databases (e.g., date, language, device category).
Capture reproducible search queries (manufacturer name, brand name, product code, key terms, date filters).
Screen each record against defined inclusion/exclusion criteria, and document the rationale for every exclusion.
Summarise clinical risks as device problems and patient problems for subject/equivalent/similar devices.
Consolidate results into a structured clinical risk summary by device category.
Document limitations (e.g., restricted filtering, missing fields, language constraints) and explain how they could influence results.

Use this vigilance and recall search report when you need traceable evidence of market signals such as complaints, adverse events, field safety actions, and recalls. It supports stronger clinical risk assessment, improves consistency during CER updates, and helps demonstrate ongoing monitoring for post-market activities.

At Lexqara, we help you integrate vigilance outputs into clinical documentation and your PMS system. We align the search protocol, screening approach, and risk summaries so your process stays consistent and inspection-ready. Explore our Resource Center [https://lexqara.com/resource-center/] and Post-Market Surveillance [https://lexqara.com/service/post-market-surveillance/]. For institutional context, use FDA MAUDE [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm]. Download the template and request a short gap assessment of your vigilance/recall process.

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Vigilance/Recall Search Report

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Approval

Author

Approval
Name:	Date:
Title:	Signature:

Evaluator

Approval
Name:	Date:
Title:	Signature:
Approval
Name:	Date:
Title:	Signature:

Revision History

Table 1: History of revision

Revision	Date	Change History

2. Deviation to the protocol 6

3. Search period 6

4. Search method 6

4.1. Vigilance/recall search database 6

4.2. Overall Search limitations 7

4.3. Inclusion and exclusion criteria 7

5. Summary of vigilance/recall search results 8

5.1. Introduction 8

5.2. Search queries and results 8

5.2.1. FDA MAUDE 8

5.2.2. FDA Medical Device Recalls 9

5.2.3. FDA TPLC 9

5.2.4. ANSM Safety Information 10

5.2.5. Bfarm Field Corrective Actions 11

5.2.6. MHRA Alerts, recalls and safety information 11

5.2.7. SwissMedic – FSCA and recall 12

5.2.8. DAEN 13

5.2.9. SARA 13

5.2.10. Canadian Recalls and Safety Alerts 14

6. Summary of clinical risks 15

6.1. Device problems 15

6.2. Patient problems 15

Acronyms

AC	Acceptance criteria
ANSM	Agence nationale de sécurité du médicament et des produits de santé
Bfarm	Bundesinstitut für arzneimittel und medizinprodukte
DAEN	Database of adverse event notifications
EU	European union
FDA	Food and drug administration
FSCA	Field safety corrective action
MAUDE	Manufacturer and User Facility Device Experience
MHRA	Medicines and healthcare products regulatory agency
SARA	System for australian recall actions
SOTA	State of the art
S&P	Safety and performance
TGA	Therapeutic goods administration
TPLC	Total product lifecycle
UK	United Kingdom
US	United States

Objective

The vigilance/recall search report has been carried out according to the protocol [protocol number and revision]. A systematic approach has been applied to collect clinical risks (i.e., device problem, patient problem) reported for [Device Name], hereafter named [device short name], its equivalent device (Objective 3 of safety and performance [S&P]) and similar devices (Objectives 2 of S&P acceptance criteria [AC]).

Deviation to the protocol

No deviation to the protocol described in Section 1.

All deviations need to be justified for their impact on the results.

Search period

The vigilance/recall search report is defined to cover the period from [start date (DD Month YYYY)] to [end date (DD Month YYYY)].

As described in the protocol indicated in Section 1, Include a justification how the period selected is appropriate (copy/paste justification from the protocol)

Search method

Vigilance/recall search database

The following vigilance/recall databases have been selected to collect clinical risks reported on the market for [device short name]/equivalent device and similar devices.

Table 2: Search databases for vigilance/recall

Vigilance / Recall database	Objective			Justification (copy/paste the justification from the protocol)
Vigilance / Recall database	SOTA	AC	S&P
FDA MAUDE		X	X	“MAUDE” is the database to report the adverse events occurred in US. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in US, hence the database is deemed relevant to collect applicable clinical risks (device or patient problem) for the S&P and AC objectives.
FDA Medical Device Recalls		X	X	“FDA Medical Device Recalls” is the database to report recalls in US. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in US, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
FDA TPLC		X		TPLC is a database that describes the types and quantity of significant adverse events and recalls reported in US for a specific product code or regulation number. As the database is not specific to the subject device, it is not used to support the S&P objective. However, the database is relevant to give an overview of clinical risks reported in US for devices with the same technology. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant.
ANSM safety information		X	X	Database with limited value as the results are only in French. “ANSM safety information” is one of the EU databases for recalls, field safety notices, and ANSM safety alerts reported in France. [Device short name] and similar devices is/are sold in France, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
Bfarm Field Corrective Actions		X	X	Database with limited value as the period of search is not sufficiently detailed. “Bfarm Field Corrective Actions” is one of the EU databases for field safety corrective actions (e.g., recall, Field safety notice) reported in Germany. [Device short name] and similar devices is/are sold in Germany, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
MHRA Alerts, recalls and safety information: drugs and medical devices		X	X	“MHRA Alerts, recalls and safety information” is a database for field safety corrective actions reported in United Kingdom (UK). [Device short name] and similar devices is/are sold in UK, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives. UK is no longer in EU but the population and clinical practices are representative of those in EU. The bias is not considered significant.
SwissMedic – FSCA and recall		X	X	“SwissMedic – FSCA and recall” is a database for field safety corrective actions reported in Switzerland. [Device short name] and similar devices is/are sold in Switzerland, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives. Switzerland is not in EU but the population and clinical practices are representative of those in EU. The bias is not considered significant.
DAEN (Database of Adverse Event Notifications) – medical devices		X	X	“DAEN” and “SARA” are databases for reporting of adverse events and recalls in Australia. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in Australia, hence the databases are deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
SARA (System for Australian Recall Actions)		X	X
Canadian recalls and safety alerts (advanced search)		X	X	Database with limited value as the period of search is not sufficiently detailed. “Canadian Recalls and safety alerts” is the database to report recalls in Canada. Though the population involved and the procedure applied may differ as compared to the population and procedure in EU, this bias is not considered significant. [Device short name] and similar devices is/are sold in Canada, hence the database is deemed relevant to collect applicable clinical risks for the S&P and AC objectives.
EUDAMED	N/A	N/A	N/A	The database is not currently available.

Overall Search limitations

The search limitation methods may differ from a database to another. Hence, this section describes the overall search limitation strategy that has been applied in the vigilance/recall search.

Table 3: Overall search limitations (table adapted from the protocol)

Type of search	Objective	Type of limitation	Description
Vigilance/recall search	AC	Search period:	See Section 3
Vigilance/recall search	S&P	Search period:	See Section 3

Inclusion and exclusion criteria

The result of vigilance / recall search is a list of events that is screened to determine if applicable to the subject device/equivalent device or similar devices (or alternative treatments when applicable). The justification for inclusion or exclusion will be documented as such in Section 5.

Summary of vigilance/recall search results

Introduction

The vigilance/recall search has been implemented according to the protocol described in Section 1 to detect the clinical risks related to the subject or equivalent devices as well as similar devices (and/or alternative treatments when applicable), and bring clinical evidence for the demonstration of S&P of [device short name] and confirm the suitability of S&P AC.

Search queries and results

FDA MAUDE

The searches in FDA MAUDE database have been carried out by: John Doe

The searches in FDA MAUDE database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the FDA MAUDE database for the identification of vigilance relevant to [Device short name]/equivalent device and similar devices.

Table 4: Vigilance search queries in the FDA MAUDE database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
FDA MAUDE	AC		Date Report Received by FDA: MM/DD/YYYY to MM/DD/YYYY	Manufacturer: Brand Name: Product Code : Note: other fields are empty
S&P		Manufacturer: Brand Name: Product Code : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

FDA MAUDE

Date Report Received by FDA: MM/DD/YYYY to MM/DD/YYYY

Manufacturer:
Brand Name:
Product Code :

Note: other fields are empty

S&P

Manufacturer:
Brand Name:
Product Code :

Note: other fields are empty

The following results have been obtained.

Table 5: Vigilance search results in the FDA MAUDE database

Query		Report Number	Event Type	Manufacturer	Brand Name	Clinical risks found or Rationale for exclusion
N°	#	Report Number	Event Type	Manufacturer	Brand Name	Device Problem	Patient Problem
Searches for AC
1
1











Searches for S&P
2
2

FDA Medical Device Recalls

The searches in FDA Medical Device Recalls database have been carried out by: John Doe

The searches in FDA Medical Device Recalls database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the FDA Medical Device Recalls database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 6: Recall search queries in the FDA Medical Device Recalls database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
FDA Medical Device Recalls	AC		Recall Date : MM/DD/YYYY to MM/DD/YYYY	Product Name : Recalling Firm : Product Code : PMA/510(K) Number : Note: other fields are empty
S&P		Product Name : Recalling Firm : Product Code : PMA/510(K) Number : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

FDA Medical Device Recalls

Recall Date : MM/DD/YYYY to MM/DD/YYYY

Product Name :
Recalling Firm :
Product Code :
PMA/510(K) Number :

Note: other fields are empty

S&P

Product Name :
Recalling Firm :
Product Code :
PMA/510(K) Number :

Note: other fields are empty

The following results have been obtained.

Table 7: Recall search results in the FDA Medical Device Recalls database

Query		Recall Number	Trade Name	Firm Name	Manufacturer Recall Reasons
N°	#	Recall Number	Trade Name	Firm Name	Manufacturer Recall Reasons
Searches for AC
1
1
Searches for S&P
2
2

FDA TPLC

The searches in FDA TPLC database have been carried out by: John Doe

The searches in FDA TPLC database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the FDA TPLC database for the identification of vigilance/recalls relevant to devices with the same product code as [Device short name].

Table 8: Vigilance/recall search queries in the FDA TPLC database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
FDA TPLC	AC		Since : YYYY	Product Code : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

FDA TPLC

Since : YYYY

Product Code :

Note: other fields are empty

The following results have been obtained.

Table 9: Recall/Vigilance search results in the FDA MAUDE database

Query	Vigilance				Recall
Query	Device problem	Occurrence or exclusion rationale	Patient problem	Occurrence or exclusion rationale	Recall Number	Reason for Recall or exclusion rationale
Searches for AC
1
1
1
1
1
1
1
1
1
1

ANSM Safety Information

The searches in ANSM Safety Information database have been carried out by: John Doe

The searches in ANSM Safety Information database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the ANSM Safety Information database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 10: Recall search queries in the ANSM Safety Information database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
ANSM safety information	AC		Type : DEFAUT QUALITE, INFORMATION AUX UTILISATEURS, RAPPEL DE PRODUIT Produits de santé : Dispositifs médicaux Date : from DD/MM/YYYY to DD/MM/YYYY	: Note: other fields are empty
S&P		: Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

ANSM safety information

Type : DEFAUT QUALITE, INFORMATION AUX UTILISATEURS, RAPPEL DE PRODUIT
Produits de santé : Dispositifs médicaux
Date : from DD/MM/YYYY to DD/MM/YYYY

Note: other fields are empty

S&P

Note: other fields are empty

The following results have been obtained.

Table 11: Recall search results in the ANSM Safety Information database

Query		Safety Action Number	Manufacturer Name	Device Name	Description of problem
N°	#	Safety Action Number	Manufacturer Name	Device Name	Description of problem
Searches for AC
1
1
Searches for S&P
2
2

Bfarm Field Corrective Actions

The searches in Bfarm Field Corrective Actions database have been carried out by: John Doe

The searches in Bfarm Field Corrective Actions database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the Bfarm Field Corrective Actions database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 12: Recall search queries in the Bfarm Field Corrective Actions database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
Bfarm Field Corrective Actions	AC		Category : Medical devices Product group of field corrective actions: select or empty Period: select	Search item : Note: other fields are empty
S&P		Search item : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

Bfarm Field Corrective Actions

Category : Medical devices
Product group of field corrective actions: select or empty
Period: select

Search item :

Note: other fields are empty

S&P

Search item :

Note: other fields are empty

The following results have been obtained.

Table 13: Recall search results in the Bfarm Field Corrective Actions database

Query		Reference	Manufacturer Name	Device Name	Description of problem
N°	#	Reference	Manufacturer Name	Device Name	Description of problem
Searches for AC
1
1
Searches for S&P
2
2

MHRA Alerts, recalls and safety information

The searches in MHRA Alerts, recalls and safety information database have been carried out by: John Doe

The searches in MHRA Alerts, recalls and safety information database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the MHRA Alerts, recalls and safety information database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 14: Recall search queries in the MHRA Alerts, recalls and safety information database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
MHRA Alerts, recalls and safety information: drugs and medical devices	AC		Message type : Field safety notice, Device safety information Medical specialty: select or empty Issued after: DD/MM/YYYY; Issued before: DD/MM/YYYY	Search : Note: other fields are empty
S&P		Search : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

MHRA Alerts, recalls and safety information: drugs and medical devices

Message type : Field safety notice, Device safety information
Medical specialty: select or empty
Issued after: DD/MM/YYYY;
Issued before: DD/MM/YYYY

Search :

Note: other fields are empty

S&P

Search :

Note: other fields are empty

The following results have been obtained.

Table 15: Recall search results in the MHRA Alerts, recalls and safety information database

Query		Reference	Manufacturer Name	Device Name	Description of problem
N°	#	Reference	Manufacturer Name	Device Name	Description of problem
Searches for AC
1
1
Searches for S&P
2
2

SwissMedic – FSCA and recall

The searches in SwissMedic – FSCA and recall database have been carried out by: John Doe

The searches in SwissMedic – FSCA and recall database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the SwissMedic – FSCA and recall database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 16: Recall search queries in the SwissMedic – FSCA and recall database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
SwissMedic – FSCA and recall	AC		From; DD/MM/YYYY To: DD/MM/YYYY	Please enter a search term: Note: other fields are empty
S&P		Please enter a search term: Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

SwissMedic – FSCA and recall

From; DD/MM/YYYY
To: DD/MM/YYYY

Please enter a search term:

Note: other fields are empty

S&P

Please enter a search term:

Note: other fields are empty

The following results have been obtained.

Table 17: Recall search results in the SwissMedic – FSCA and recall database

Query		Swissmedic Reference	Manufacturer	Trade Name	Description of problem
N°	#	Swissmedic Reference	Manufacturer	Trade Name	Description of problem
Searches for AC
1
1
Searches for S&P
2
2

DAEN

The searches in DAEN database have been carried out by: John Doe

The searches in DAEN database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the DAEN database for the identification of vigilance relevant to [Device short name]/equivalent device and similar devices.

Table 18: Vigilance search queries in the DAEN database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
DAEN (Database of Adverse Event Notifications) – medical devices	AC		Select date range : From : YYYY Month DD To : YYYY Month DD	Select medical devices : Note: other fields are empty
S&P		Select medical devices : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

DAEN (Database of Adverse Event Notifications) – medical devices

Select date range :
From : YYYY Month DD
To : YYYY Month DD

Select medical devices :

Note: other fields are empty

S&P

Select medical devices :

Note: other fields are empty

The following results have been obtained.

Table 19: Vigilance search results in the DAEN database

Query		Report Number	Manufacturer	Trade Name	Event description
N°	#	Report Number	Manufacturer	Trade Name	Event description
Searches for AC
1
1
Searches for S&P
2
2

SARA

The searches in SARA database have been carried out by: John Doe

The searches in SARA database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the SARA database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 20: Recall search queries in the SARA database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
SARA (System for Australian Recall Actions)	AC		Select product type : Medical Device Select date range : From : YYYY Month DD To : YYYY Month DD	Select products : Note: other fields are empty
S&P		Select products : Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

SARA (System for Australian Recall Actions)

Select product type : Medical Device
Select date range :
From : YYYY Month DD
To : YYYY Month DD

Select products :

Note: other fields are empty

S&P

Select products :

Note: other fields are empty

The following results have been obtained.

Table 21: Recall search results in the SARA database

Query		TGA Recall Reference	Responsible Entity	Product Name	Reason/Issue
N°	#	TGA Recall Reference	Responsible Entity	Product Name	Reason/Issue
Searches for AC
1
1
Searches for S&P
2
2

Canadian Recalls and Safety Alerts

The searches in Canadian Recalls and Safety Alerts database have been carried out by: John Doe

The searches in Canadian Recalls and Safety Alerts database have been implemented on: DD/MM/YYYY

The following table describes the search queries and number of results obtained in the Canadian Recalls and Safety Alerts database for the identification of recalls relevant to [Device short name]/equivalent device and similar devices.

Table 22: Recall search queries in the Canadian Recalls and Safety Alerts database (adapted from the protocol)

Literature database	Objective	Query	General limitations	Keywords	Number of results
Canadian recalls and safety alerts (advanced search)	AC		Type: Recall Issue: Medical devices Last updated: YYYY	Search: Note: other fields are empty
S&P		Search: Note: other fields are empty

Literature database

Objective

Query

General limitations

Keywords

Number of results

Canadian recalls and safety alerts (advanced search)

Type: Recall
Issue: Medical devices
Last updated: YYYY

Search:

Note: other fields are empty

S&P

Search:

Note: other fields are empty

The following results have been obtained.

Table 23: Recall search results in the Canadian Recalls and Safety Alerts database

Query		Identification Number	Companies	Product	Description of problem
N°	#	Identification Number	Companies	Product	Description of problem
Searches for AC
1
1
Searches for S&P
2
2

Summary of clinical risks

For the period of search indicated in Section 3, device problems and patients problems have been reported for the subject device/equivalent device (objective 3) and similar devices (objective 2), in the publicly available vigilance/recall databases.

The following sections will describe the summary of results obtained.

Device problems

The following table presents the device problems reported for the subject device/equivalent device and similar devices.

Table 24: Device problems

Device problem	Occurrence	Comment
Subject device: [Device short name]


Equivalent device: AAA


Similar device: XXX


Similar device: YYY

Patient problems

The following table presents the patient problems reported for the subject device/equivalent device and similar devices.

Table 25: Patient problems

Patient problem	Occurrence	Comment
Subject device: [Device short name]


Equivalent device: AAA


Similar device: XXX


Similar device: YYY

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Search report for vigilance / recall