ICD COBALT XT DR MRI IS1 DF1 — Class I medical device recall Z-1721-2023
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-1721-2023 |
|---|---|
| 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 | 2,748 units |
| UPC / GTIN / UDI-DI | 00763000178338, 00763000178352, 00763000380366 |
| Lot numbers | RSL600037S, RSL600042S, RSL600043S, RSL600044S, RSL600063S, RSL600064S, RSL600066S, RSL600069S, RSL600077S, RSL600082S, RSL600083S, RSL600107S, RSL600124S, RSL600127S, RSL600128S, RSL600131S, RSL600132S, RSL600134S, RSL600135S, RSL600136S, RSL600137S, RSL600138S, RSL600139S, RSL600140S, RSL600143S, RSL600144S, RSL600146S, RSL600158S, RSL600170S, RSL600183S, RSL600325S, RSL600408S, RSL600450S, RSL600476S, RSL600696S, RSL600731S, RSL600732S, RSL600734S, RSL600735S, RSL600737S and 460 more |
| Serial numbers | RSL600036S, RSL600149S, RSL600150S, RSL600152S, RSL600153S, RSL600154S, RSL600156S, RSL600162S, RSL600163S, RSL600165S, RSL600167S, RSL600168S, RSL600172S, RSL600174S, RSL600175S, RSL600176S, RSL600178S, RSL600181S, RSL600184S, RSL600185S, RSL600186S, RSL600191S, RSL600192S, RSL600193S, RSL600194S and 475 more |
| Model numbers | DDPA2D1 |
Product
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; 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-1721-2023. 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.