Cobalt Implantable Cardioverter Defibrillators: a — Class I medical device recall Z-1485-2022
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2022-08-17. There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy f
| Recall number | Z-1485-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2022-06-22 |
| Classified | 2022-08-08 |
| Reported by FDA | 2022-08-17 |
| Quantity | 6,884 units |
| UPC / GTIN / UDI-DI | 00763000178338, 00763000178345, 00763000178352, 00763000178369, 00763000178451, 00763000178468, 00763000178475, 00763000178482, 00763000380366, 00763000380373, 00763000380380, 00763000380397 |
| Serial numbers | DDPA2D4, DVPA2D4, RSC600021S, RSC600025S, RSC600029S, RSC600031S, RSC600037S, RSC600053S, RSC600056S, RSC600057S, RSC600059S, RSC600062S, RSC600063S, RSC600067S, RSC600068S, RSC600070S, RSC600072S, RSC600073S, RSC600076S, RSC600077S, RSC600078S, RSC600083S, RSC600088S, RSC600089S, RSC600090S and 475 more |
| Model numbers | DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 |
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Reason for recall
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
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-1485-2022. 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.