St. Jude Medical recalls Merlin 2 PCS MER37000 programmer software version 1.1.2 rev 1 or earlier due to potential device malfunction. Affected units have specific UDI/DI numbers.
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
St. Jude Medical is recalling a software update for their Merlin 2 PCS programmer model MER3400. This software version could cause device malfunctions, which may lead to health risks for users with implanted medical devices.
The software update could cause the programmer to malfunction, potentially leading to incorrect device programming or data transmission. This might affect the proper functioning of the implanted medical device.
People with implanted medical devices who use the Merlin 2 PCS programmer software version 1.1.2 rev 1 or earlier are affected. Those with cardiac rhythm management devices are most at risk.
Check for the software version number 1.1.2 rev 1 or earlier on the Merlin 2 PCS programmer. Affected units have the UDI/DI number 05415067037121.
Look for software version 1.1.2 rev 1 or earlier on the Merlin 2 PCS programmer.
Install the latest software update from St. Jude Medical to resolve the issue.
The recalled software version is 1.1.2 rev 1 or earlier.
Check for the software version number 1.1.2 rev 1 or earlier and the UDI/DI number 05415067037121.
No, but you should update the software to the latest version to prevent potential malfunctions.
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-1496-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1496-2022 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.
