Medtronic COBALT HF QUAD CRT-D MRI SureScan — Class II medical device recall Z-0926-2021
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-02-03, distributed in GA, NJ, PA. Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device per
| Recall number | Z-0926-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2020-11-15 |
| Classified | 2021-01-26 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2025-12-23 |
| Distributed | GA, NJ, PA |
| Countries outside the US | FR |
| Quantity | 2 units |
| Serial numbers | RTK602501S, RTK602506S |
| Model numbers | DTPB2QQ |
Product
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Reason for recall
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
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-0926-2021. 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.