ICD COBALT XT VR MRI IS1 DF1 — Class I medical device recall Z-1818-2023
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-1818-2023 |
|---|---|
| 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 | 2,000 units |
| UPC / GTIN / UDI-DI | 00763000178451, 00763000178475, 00763000380380 |
| Serial numbers | RSC600018S, RSC600019S, RSC600021S, RSC600025S, RSC600029S, RSC600031S, RSC600037S, RSC600053S, RSC600056S, RSC600057S, RSC600059S, RSC600062S, RSC600063S, RSC600067S, RSC600068S, RSC600070S, RSC600072S, RSC600073S, RSC600076S, RSC600077S, RSC600078S, RSC600083S, RSC600088S, RSC600089S, RSC600090S and 475 more |
| Model numbers | DVPA2D1 |
Product
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; 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-1818-2023. 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.