St Jude Medical recalls Merlin PCS Programmer software model 3330 used with Confirm Rx ICM Model DM3500. Devices may display a low battery indicator due to memory corruption. Affected units have specific serial numbers listed in the recall notice.
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
St Jude Medical is recalling Merlin PCS Programmer software model 3330 used with Confirm Rx Insertable Cardiac Monitors (ICM) Model DM3500. The software may incorrectly display a low battery indicator due to memory corruption, which could lead to improper device operation. This recall affects specific units with listed serial numbers.
The software may display a low battery indicator incorrectly due to memory corruption. This could cause the device to appear to need battery replacement when it does not, potentially leading to improper monitoring of cardiac conditions.
Patients using the Confirm Rx ICM Model DM3500 with Merlin PCS Programmer software model 3330 are most at risk. The recall applies to specific units with listed serial numbers.
Check if your Confirm Rx ICM has the model number DM3500 and the Merlin PCS Programmer software version 24.0.1 rev 1. Affected units have specific serial numbers listed in the recall notice.
Verify your Confirm Rx ICM's serial number against the list of affected units provided in the recall notice.
The affected software version is Merlin PCS Programmer software model 3330, version 24.0.1 rev 1.
Check your Confirm Rx ICM's serial number against the list of affected serial numbers provided in the recall notice.
The recall does not specify a fix; users are advised to check if their device is affected and contact St Jude Medical for further instructions.
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-0808-2020 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-0808-2020 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.
