CRTD COBALT XT HF MRI IS1 DF1 — Class I medical device recall Z-1774-2023
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2023-06-28, distributed nationwide. There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J)
| Recall number | Z-1774-2023 |
|---|---|
| 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 | 2023-05-10 |
| Classified | 2023-06-16 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 4,151 units |
| UPC / GTIN / UDI-DI | 00763000178147, 00763000178161, 00763000402204 |
| Serial numbers | RTH600017S, RTH600035S, RTH600036S, RTH600041S, RTH600044S, RTH600046S, RTH600061S, RTH600062S, RTH600063S, RTH600071S, RTH600072S, RTH600080S, RTH600083S, RTH600092S, RTH600094S, RTH600095S, RTH600096S, RTH600097S, RTH600100S, RTH600101S, RTH600102S, RTH600103S, RTH600104S, RTH600105S, RTH600107S and 475 more |
| Model numbers | DTPA2D1 |
Product
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
Reason for recall
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and 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-1774-2023. 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.