Crome Implantable Cardioverter Defibrillators: a — Class I medical device recall Z-1489-2022
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-1489-2022 |
|---|---|
| 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 | 1,657 units |
| UPC / GTIN / UDI-DI | 00763000178413, 00763000178420, 00763000178437, 00763000178444, 00763000178543, 00763000178550, 00763000178567 |
| Serial numbers | DDPC3D4, DVPC3D4, RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG600011S, RSG600012S, RSG600013S, RSG600014S, RSG600017S, RSG600018S, RSG600020S, RSG600022S, RSG600023S, RSG600024S, RSG600025S, RSG600026S, RSG600027S, RSG600028S, RSG600029S, RSG600030S, RSG600031S, RSG600033S, RSG600036S and 475 more |
| Model numbers | DDPC3D1, DDPC3D4, DVPC3D1, DVPC3D4 |
Product
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
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-1489-2022. 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.