Cobalt Implantable Cardioverter Defibrillators: a — Class I medical device recall Z-1487-2022
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-1487-2022 |
|---|---|
| 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 | 2,866 units |
| UPC / GTIN / UDI-DI | 00763000178376, 00763000178383, 00763000178390, 00763000178406, 00763000178499, 00763000178505, 00763000178512, 00763000178529 |
| Serial numbers | DDPB3D4, DVPB3D4, RSE600007S, RSE600009S, RSE600011S, RSE600012S, RSE600014S, RSE600015S, RSE600016S, RSE600017S, RSE600019S, RSE600020S, RSE600023S, RSE600024S, RSE600025S, RSE600028S, RSE600030S, RSE600033S, RSE600034S, RSE600036S, RSE600041S, RSE600042S, RSE600044S, RSE600046S, RSE600048S and 475 more |
| Model numbers | DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 |
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
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-1487-2022. 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.