Abbott Medical recalls Merlin PCS 3650 programmer model 3330 due to software anomaly that may cause leadless pacemaker programming failure with temporary loss of telemetry. Affected units have specific software versions and serial numbers listed in the recall notice.
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, 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 Programmer displays a loss of telemetry detected window, and there is no pacing.
Abbott Medical is recalling its Merlin PCS 3650 programmer model 3330 because a software issue can cause programming failures during leadless pacemaker finalization, resulting in temporary loss of telemetry and no pacing. This could lead to improper device function if not corrected.
During finalization of leadless pacemaker programming, a specific sequence of actions combined with a brief loss of telemetry (<2 seconds) can cause the programming step to fail. If this occurs, the device displays a 'loss of telemetry detected' message and stops pacing, potentially leading to improper device function.
Users of the Merlin PCS 3650 programmer model 3330 with specific software versions (28.0.1 REV 2) and serial numbers listed in the recall notice are affected. Medical professionals who program leadless pacemakers with this device are most at risk.
Check if your Merlin PCS 3650 programmer has software version 28.0.1 REV 2 and one of the serial numbers listed in the recall notice (many are provided in the record). The device is used for programming Abbott Medical implantable devices.
Verify your Merlin PCS 3650 programmer has software version 28.0.1 REV 2 and one of the serial numbers listed in the recall notice.
Affected units have software version 28.0.1 REV 2.
Check if your Merlin PCS 3650 programmer has software version 28.0.1 REV 2 and one of the serial numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0753-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0753-2025 from Abbott Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
