St. Jude Medical recalls Merlin 2 PCS MER3700 programmer software version v1.X.X (serial numbers listed) due to potential incorrect test execution during in-clinic procedures on implantable defibrillators.
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
St. Jude Medical is recalling Merlin 2 PCS MER3700 programmers with specific software versions that may continue running a test instead of stopping when performing a pacing capture decrement test on implantable defibrillators. This could lead to incorrect device settings being applied during medical procedures.
During a specific in-clinic test called a pacing capture decrement test, the software may fail to terminate the test and restore normal device settings. This could cause incorrect programming of the device, potentially affecting how the device delivers shocks or pacing.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy devices who use the Merlin 2 PCS MER3700 programmer software. Medical professionals performing in-clinic procedures with these devices are most at risk.
The Merlin 2 PCS MER3700 programmer with software version v1.X.X (serial numbers listed in the recall notice). This software is used with implantable cardioverter defibrillators.
Verify the software version on your Merlin 2 PCS MER3700 programmer. If it shows version v1.X.X, it is affected.
The recall addresses a potential issue during in-clinic procedures, not direct patient risk. The hazard is specific to the test execution process by medical professionals.
Check the software version on your Merlin 2 PCS MER3700 programmer. Affected units have software version v1.X.X with the serial numbers listed in the recall notice.
No action is required if your software version is not v1.X.X. Only affected units need to verify their software version.
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-0965-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0965-2022 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.
