Crome Implantable Cardioverter Defibrillators with Cardiac… — Class I medical device recall Z-1490-2022
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-1490-2022 |
|---|---|
| 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 | 866 units |
| UPC / GTIN / UDI-DI | 00763000178253, 00763000178260, 00763000178277, 00763000178284, 00763000178291, 00763000178307, 00763000178314, 00763000178321 |
| Serial numbers | DTPC2D1, DTPC2Q1, RTS600014S, RTS600015S, RTS600016S, RTS600017S, RTS600018S, RTS600020S, RTS600022S, RTS600024S, RTS600026S, RTS600027S, RTS600029S, RTS600030S, RTS600031S, RTS600032S, RTS600034S, RTS600035S, RTS600036S, RTS600037S, RTS600038S, RTS600039S, RTS600041S, RTS600042S, RTS600043S and 475 more |
| Model numbers | DTPC2D1, DTPC2D4, DTPC2Q1, DTPC2QQ |
Product
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
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-1490-2022. 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.