Public recall detail

Merlin™ 3650 Patient Care System (PCS)

2026-05-22

medium
Health products Health product recall
Quick summary

Quick summary: Merlin™ 3650 Patient Care System (PCS). Reason: Health product recall. Category: Health products. Date: 2026-05-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Merlin™ 3650 Patient Care System (PCS). Reason: Health product recall. Category: Health products. Date: 2026-05-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSt. Jude Medical, Cardiac Rhythm Management Division
ProductMerlin™ 3650 Patient Care System (PCS)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82105

Affected products

ProductMerlin Patient Care System - Programmer
LotNot applicable.
Model3650
Serial numberNot applicable.
DescriptionMerlin Patient Care System - Programmer
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.1.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 VER 25.2.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V25.8.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V26.0.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V27.0.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.8.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V25.4.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.3.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.2.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 VER 25.0.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 VER 25.3.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.0.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit
ProductMerlin PCS 3330 Software Upgrade Kit
LotNot applicable.
Model3330 V28.5.4
Serial numberNot applicable.
DescriptionMerlin PCS 3330 Software Upgrade Kit

Issue

Abbott is reaching out to customers to inform about a Merlin™ PCS 3650 programmer software update that addresses a software behavior that may occur during Pacing Capture Threshold (PCT) test of an AVEIR™ Leadless Pacemaker (LP). If intermittent loss of telemetry occurs during PCT test, the programmer may not successfully communicate the command to terminate the test, potentially leaving the LP in sub-threshold pacing until telemetry is fully disconnected. This issue can only occur during a PCT test, which is performed during implant or in clinic follow-up. This issue was identified through a review of complaints data, which confirmed four (4) complaints associated with the issue globally.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesSt. Jude Medical, Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, United States, 91342
Recall date2026-05-12
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82105
Background{}
CompaniesSt. Jude Medical, Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, United States, 91342
AudiencesHealthcare
Source updated2026-05-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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