ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB — Class I medical device recall Z-1710-2023
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-1710-2023 |
|---|---|
| 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 | 4,056 units |
| UPC / GTIN / UDI-DI | 00643169720381, 00643169720398, 00643169980235, 00763000612108 |
| Serial numbers | BWF206175H, BWF206176H, BWF206317H, BWF206318H, BWF206320H, BWF206321H, BWF206322H, BWF206323H, BWF206327H, BWF206333H, BWF206334H, BWF206338H, BWF206340H, BWF206341H, BWF206342H, BWF206344H, BWF206345H, BWF206347H, BWF206349H, BWF206353H, BWF206355H, BWF206357H, BWF206358H, BWF206359H, BWF206360H and 475 more |
| Model numbers | DDBC3D4 |
Product
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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-1710-2023. 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.