ICD-DR DDMD3D4 PRIMO MRI — Class I medical device recall Z-1718-2023
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-1718-2023 |
|---|---|
| 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 | 11,239 units |
| UPC / GTIN / UDI-DI | 00763000001506, 00763000001513, 00763000611927 |
| Lot numbers | CWN600139S, CWN600140S, CWN600141S, CWN600142S, CWN600148S, CWN600152S, CWN600153S, CWN600154S, CWN600155S, CWN600156S, CWN600162S, CWN600164S, CWN600166S, CWN600167S, CWN600168S, CWN600169S, CWN600170S, CWN600171S, CWN600172S, CWN600175S, CWN600176S, CWN600178S, CWN600179S, CWN600180S, CWN600181S, CWN600187S, CWN600189S, CWN600190S, CWN600191S, CWN600193S, CWN600194S, CWN600197S, CWN600206S, CWN600207S, CWN600208S, CWN600210S, CWN600212S, CWN600215S, CWN600216S, CWN600217S and 460 more |
| Serial numbers | 67S, CWN600021S, CWN600022S, CWN600024S, CWN600028S, CWN600032S, CWN600038S, CWN600039S, CWN600047S, CWN600049S, CWN600050S, CWN600053S, CWN600055S, CWN600056S, CWN600057S, CWN600058S, CWN600059S, CWN600060S, CWN600062S, CWN600065S, CWN600066S, CWN600068S, CWN600069S, CWN600070S, CWN600071S and 475 more |
| Model numbers | DDMD3D4 |
Product
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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-1718-2023. 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.