Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator — Class II medical device recall Z-0779-2024
Ongoing recall by Medtronic Inc., reported 2024-01-31, distributed nationwide. During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noti
| Recall number | Z-0779-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Mounds View, MN, United States |
| Recall initiated | 2023-12-07 |
| Classified | 2024-01-22 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 1 devices |
| UPC / GTIN / UDI-DI | 00763000178338 |
| Serial numbers | RSL604096S |
Product
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Reason for recall
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
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-0779-2024. 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.