ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT — Class I medical device recall Z-1714-2023
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-1714-2023 |
|---|---|
| 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 | 35,961 units |
| UPC / GTIN / UDI-DI | 00643169443419, 00643169720503, 00643169720510, 00763000206147, 00763000612009 |
| Serial numbers | 29637S, 40931S, 5005S, 51864S, 623196S, GZ654849S, PGZ6, PGZ619625S, PGZ619626S, PGZ619627S, PGZ619628S, PGZ619629S, PGZ619630S, PGZ620778S, PGZ620779S, PGZ620780S, PGZ620781S, PGZ620782S, PGZ620783S, PGZ620784S, PGZ620785S, PGZ620786S, PGZ620787S, PGZ620788S, PGZ620789S and 475 more |
| Model numbers | DDMB2D4 |
Product
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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-1714-2023. 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.