ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB — Class I medical device recall Z-1716-2023
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-1716-2023 |
|---|---|
| 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 | 37,547 units |
| UPC / GTIN / UDI-DI | 00643169720527, 00643169720534, 00643169720541, 00763000059705, 00763000206185 |
| Serial numbers | 007S, 22591S, 24125S, 30718S, 5679S, PHZ202131H, PHZ202133H, PHZ202134H, PHZ202519H, PHZ202520H, PHZ202522H, PHZ202523H, PHZ202525H, PHZ202526H, PHZ202527H, PHZ202528H, PHZ202529H, PHZ202530H, PHZ202531H, PHZ202532H, PHZ202533H, PHZ202534H, PHZ202535H, PHZ202536H, PHZ202538H and 475 more |
| Model numbers | DDMC3D4 |
Product
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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-1716-2023. 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.