St. Jude Medical recalls Merlin PCS 365:3650 programmer software version 3330 v26.0.1 rev 1 or earlier for potential overestimated battery life displays in pacemakers.
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
St. Jude Medical is recalling a specific software version for their Merlin PCS 3650 programmer. This software might show a longer battery life than actually exists, which could lead to unexpected battery failure in pacemakers.
The software may display a battery life that is longer than the actual remaining battery life. This could cause the pacemaker to stop working unexpectedly when the battery runs out sooner than expected.
Pacemaker users with the Merlin PCS 3650 programmer software version 3330 v26.0.1 rev 1 or earlier are affected. Those with pacemakers that rely on accurate battery life displays are at higher risk.
Check if your Merlin PCS 3650 programmer has software version 3330 v26.0.1 rev 1 or earlier. The unique device identifier (UDI/DI) 05414734509725 is also associated with this software version.
Update to the latest software version to ensure accurate battery life displays.
No, this recall specifically affects pacemakers with the Merlin PCS 3650 programmer software version 3330 v26.0.1 rev 1 or earlier.
The software may show a longer battery life than actual, which could lead to unexpected battery failure in pacemakers.
Check your Merlin PCS 3650 programmer for software version 3330 v26.0.1 rev 1 or earlier, or look for the UDI/DI 05414734509725.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1495-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1495-2022 from St. Jude 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.
