CRTD COBALT XT HF MRI IS1 DF4 — Class I medical device recall Z-1777-2023
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-1777-2023 |
|---|---|
| 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 | 1,914 units |
| UPC / GTIN / UDI-DI | 00763000178130, 00763000178154, 00763000402211 |
| Serial numbers | RTG600025S, RTG600028S, RTG600029S, RTG600030S, RTG600033S, RTG600036S, RTG600037S, RTG600040S, RTG600048S, RTG600049S, RTG600054S, RTG600055S, RTG600056S, RTG600059S, RTG600060S, RTG600061S, RTG600062S, RTG600063S, RTG600064S, RTG600065S, RTG600066S, RTG600067S, RTG600068S, RTG600069S, RTG600070S and 475 more |
| Model numbers | DTPA2D4 |
Product
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; 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-1777-2023. 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.