St. Jude Medical Confirm Rx Insertable Cardiac Monitor (REF DM3500) fails to pair with mobile app due to certificate expiration error. Affected units have serial numbers listed in the recall notice.
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Abbott is recalling St. Jude Medical Confirm Rx Insertable Cardiac Monitors (REF DM3500) because they cannot pair with the mobile app due to a certificate expiration error. This issue does not pose a health risk but may prevent proper monitoring of heart conditions.
The device incorrectly determines the certificate has expired, preventing it from pairing with the mobile app. This means the monitor cannot wirelessly transmit data to the Merlin.net Patient Care Network for monitoring heart conditions. However, the device itself remains functional and does not cause injury.
Patients using the St. Jude Medical Confirm Rx Insertable Cardiac Monitor (REF DM3500) for heart condition monitoring are affected. Those with atrial fibrillation or unexplained symptoms like dizziness or chest pain are most at risk.
Check if your device has the serial numbers listed in the recall notice: 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 9224490, 9224503, 9224525, 9224529, 9225190, 9225203, 9225205, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242219, 9242225, 9242231, 9256057.
Identify your device's serial number and compare it to the list of affected numbers provided in the recall notice.
No, the device remains functional but cannot pair with the mobile app. It does not cause injury or health risks.
Check if your device has one of the serial numbers listed in the recall notice: 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 9224490, 9224503, 9224525, 9224529, 9225190, 9225203, 9225205, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242219, 9242225, 9242231, 9256057.
The recall does not require immediate action. Check the device's serial number and contact Abbott for further guidance if needed.
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-1220-2019 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1220-2019 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.
