FDA Device recall Z-0808-2020
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile by St Jude Medical Cardiac Rhythm Management Division, citing devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0808-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-13 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM 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
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Identifiers
| code_info | Merlin PCS Programmer Software, V24.0.1 rev 1, UDI 05414734509725. Confirm Rx ICM, UDI 05415067027320, US serial num…Merlin PCS Programmer Software, V24.0.1 rev 1, UDI 05414734509725. Confirm Rx ICM, UDI 05415067027320, US serial numbers: 3161783 3165630 3169553 3172363 3175335 3175336 3175337 3175349 3175356 3175377 3175378 3175385 3175393 3175394 3175395 3175399 3175402 3178901 3178907 3178909 3178916 3178919 3178921 3178930 3178937 3178943 3178945 3178946 3178951 3178954 3178962 3178969 3178974 3178981 3178995 3179005 3179024 3179103 3179123 3179149 3179177 3179199 3179260 3179443 3179452 3179520 3179533 3179539 3179542 3179543 3179570 3179583 3179589 3179595 3179603 3179609 3179850 3179851 3179921 3179929 3179953 3179965 3179972 3179988 3179991 3179997 3180019 3180030 3180038 3180309 3180326 3180333 3180411 3180420 3180421 3180424 3180578 3180604 3180607 3180608 3180617 3180661 3180675 3180679 3180692 3180695 3180704 3180969 3181038 3181066 3181067 3181168 3181171 3181174 3181175 3181199 3181203 |
|---|
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-0808-2020%22
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