Cobalt Models loaded with CareLink SmartSync Device Manager… — Class II medical device recall Z-1267-2022
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-1267-2022 |
|---|---|
| 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 | 51,922 units |
| UPC / GTIN / UDI-DI | 00763000178093, 00763000178109, 00763000178116, 00763000178123, 00763000178130, 00763000178147, 00763000178154, 00763000178161, 00763000178178, 00763000178185, 00763000178192, 00763000178208, 00763000178215, 00763000178222, 00763000178239, 00763000178246, 00763000178338, 00763000178345, 00763000178352, 00763000178369, 00763000178376, 00763000178383, 00763000178390, 00763000178406, 00763000178451 and 17 more |
| Serial numbers | 01291S, 01854S, 04905S, 25S, 600379S, 649S, 822S, C603386S, O601507S, RSC600018S, RSC600019S, RSC600021S, RSC600025S, RSC600029S, RSC600031S, RSC600037S, RSC600053S, RSC600056S, RSC600057S, RSC600059S, RSC600062S, RSC600063S, RSC600067S, RSC600068S, RSC600070S and 475 more |
| Model numbers | DDPA2D1, DDPA2D4, DDPB3D1, DDPB3D4, DTPA2D1, DTPA2D1PX, DTPA2D4, DTPA2Q1, DTPA2QQ, DTPA2QQPX, DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ, DVPA2D1, DVPA2D4, DVPB3D1, DVPB3D4 |
Product
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; h) Cobalt HF Quad: DTPB2QQ, DTPB2Q1
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-1267-2022. 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.