Cobalt Implantable Cardioverter Defibrillators with Cardiac… — Class II medical device recall Z-1480-2022
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2022-08-03, distributed nationwide. Manufacturing error that may have resulted in a cathode component being out of specification. All devices met
| Recall number | Z-1480-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2020-11-05 |
| Classified | 2022-07-28 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00763000178178 |
| Serial numbers | RTK601825S, RTK601828S, RTK601865S |
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reason for recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
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-1480-2022. 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.