FDA Device recall Z-1220-2019
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile by Abbott, citing the device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1220-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-19 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott |
| Distribution | US |
Product
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Reason
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Identifiers
| code_info | Serial numbers 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 92244…Serial numbers 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, and 9256057. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2019%22
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