CRTD CROME HF MRI IS1 DF4 — Class I medical device recall Z-1786-2023
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-1786-2023 |
|---|---|
| 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 | 476 units |
| UPC / GTIN / UDI-DI | 00763000178291, 00763000178314 |
| Serial numbers | RTW600008S, RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600048S, RTW600049S, RTW600052S, RTW600053S, RTW600054S, RTW600056S, RTW600057S, RTW600059S, RTW600062S, RTW600065S and 451 more |
| Model numbers | DTPC2D4 |
Product
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; 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-1786-2023. 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.