St — Class II medical device recall Z-1220-2019
Terminated recall by Abbott, reported 2019-05-01, distributed nationwide. The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has
| Recall number | Z-1220-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Sylmar, CA, United States |
| Recall initiated | 2018-11-19 |
| Classified | 2019-04-25 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 32 devices |
| Serial numbers | 9224490, 9224501, 9224503, 9224508, 9224525, 9224529, 9225179, 9225190, 9225191, 9225193, 9225203, 9225205, 9225207, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242209, 9242219 and 7 more |
| Model numbers | DM3500 |
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 for recall
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1220-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.