Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators… — Class II medical device recall Z-1650-2021
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-05-26, distributed nationwide. The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
| Recall number | Z-1650-2021 |
|---|---|
| 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 | 2021-04-07 |
| Classified | 2021-05-20 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2024-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 00763000178215 |
| Serial numbers | RTO601595S, RTO601624S |
Product
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Reason for recall
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
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-1650-2021. 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.