Crome Models loaded with CareLink SmartSync Device Manager… — Class II medical device recall Z-1268-2022
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2022-06-22, distributed nationwide. Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs)
| Recall number | Z-1268-2022 |
|---|---|
| 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 | 2022-04-12 |
| Classified | 2022-06-14 |
| Reported by FDA | 2022-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IS, IT, JP, KR, KW, LU, MY, NL, NO, NZ, PA, PL, PT, QA, RO, SA, SE, SG, SK, TH, UY |
| Quantity | 3,944 units |
| UPC / GTIN / UDI-DI | 00763000178253, 00763000178260, 00763000178277, 00763000178284, 00763000178291, 00763000178307, 00763000178314, 00763000178321, 00763000178413, 00763000178420, 00763000178437, 00763000178444, 00763000178536, 00763000178543, 00763000178550, 00763000178567 |
| Serial numbers | RSG600006S, RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG600011S, RSG600012S, RSG600013S, RSG600014S, RSG600016S, RSG600017S, RSG600018S, RSG600020S, RSG600022S, RSG600023S, RSG600024S, RSG600025S, RSG600026S, RSG600027S, RSG600028S, RSG600029S, RSG600030S, RSG600031S, RSG600033S, RSG600036S and 475 more |
| Model numbers | DDPC3D1, DDPC3D4, DTPC2D1, DTPC2D4, DTPC2Q1, DTPC2QQ, DVPC3D1, DVPC3D4 |
Product
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Reason for recall
Telemetry error that may occur with Medtronic 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-1268-2022. 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.