CanadaMerlin 3650 Patient Care System (PCS) programmer (model 3650) and Merlin PCS 3330 software upgrade kits with the catalogue numbers/software versions listed in the notice are affected. A software behavior during a Pacing Capture Threshold (PCT) test of an AVEIR leadless pacemaker may, if intermittent telemetry loss occurs, prevent the programmer from communicating the command to terminate the test and could leave the pacemaker pacing below threshold until telemetry is fully disconnected. Contact the manufacturer for additional information.
What's being recalled
Companies: St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, California, United States, 91342.
How to identify it
Affected products: Merlin Patient Care System - Programmer; Lot or serial number: Not applicable.; Model or catalogue number: 3650
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.1.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 VER 25.2.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V25.8.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V26.0.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V27.0.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.8.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V25.4.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.3.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.2.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 VER 25.0.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 VER 25.3.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.0.4
Affected products: Merlin PCS 3330 Software Upgrade Kit; Lot or serial number: Not applicable.; Model or catalogue number: 3330 V28.5.4
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)