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Merlin pcs 3330 software upgrade kit
Official notice
6 Dec 2024
An official Health Canada notice concerns Merlin pcs 3330 software upgrade kit. Abbott is informing customers of a programmer software anomaly that may be encountered in a very specific circumstance during finalization of the AVEIR™ DR leadless pacemaker (LP) system. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. A specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Merlin™ PCS 3650 programmer displays a "loss of telemetry detected" window, and there is no pacing. Atrial sense markers coincident to intrinsic QRS complexes may be observed. Subsequent attempts to finalize the device will also result in a "loss of telemetry detected" window. Full functionality, including ability to finalize the device and restore pacing, is reinstated through Abbott technical services intervention. Recall start date: November 22, 2024 Published 2024-12-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76652
Official notice
2024-12-06
The hazard
The hazard
Abbott is informing customers of a programmer software anomaly that may be encountered in a very specific circumstance during finalization of the AVEIR™ DR leadless pacemaker (LP) system. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. A specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Merlin™ PCS 3650 programmer displays a "loss of telemetry detected" window, and there is no pacing. Atrial sense markers coincident to intrinsic QRS complexes may be observed. Subsequent attempts to finalize the device will also result in a "loss of telemetry detected" window. Full functionality, including ability to finalize the device and restore pacing, is reinstated through Abbott technical services intervention. Recall start date: November 22, 2024
How to check if you're affected
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Brand: St Jude Medical Cardiac Rhythm Management Division, Merlin Pcs 3330 Software Upgrade Kit.
Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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