ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1 — Class I medical device recall Z-1715-2023
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-1715-2023 |
|---|---|
| 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 | 10,903 units |
| UPC / GTIN / UDI-DI | 00643169837737, 00643169837744, 00763000060015, 00763000206192 |
| Serial numbers | 1924S, CWC200777H, CWC200780H, CWC200922H, CWC200923H, CWC200925H, CWC200926H, CWC200927H, CWC200928H, CWC200929H, CWC200931H, CWC200932H, CWC200934H, CWC200935H, CWC200936H, CWC200937H, CWC200938H, CWC200939H, CWC200940H, CWC200941H, CWC200942H, CWC200944H, CWC200945H, CWC200947H, CWC200948H and 475 more |
| Model numbers | DDMC3D1 |
Product
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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-1715-2023. 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.