ICD-DR DDME3D1 MIRRO MRI — Class I medical device recall Z-1719-2023
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-1719-2023 |
|---|---|
| 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 | 2,831 units |
| UPC / GTIN / UDI-DI | 00763000001568, 00763000001575, 00763000611934 |
| Lot numbers | CWS600003S, CWS600004S, CWS600005S, CWS600006S, CWS600007S, CWS600008S, CWS600009S, CWS600011S, CWS600012S, CWS600013S, CWS600014S, CWS600015S, CWS600017S, CWS600018S, CWS600021S, CWS600022S, CWS600023S, CWS600026S, CWS600027S, CWS600029S, CWS600031S, CWS600033S, CWS600034S, CWS600035S, CWS600036S, CWS600044S, CWS600046S, CWS600047S, CWS600048S, CWS600049S, CWS600050S, CWS600051S, CWS600052S, CWS600053S, CWS600055S, CWS600056S, CWS600057S, CWS600058S, CWS600059S, CWS600060S and 78 more |
| Serial numbers | CWS600097S, CWS600098S, CWS600101S, CWS600102S, CWS600103S, CWS600104S, CWS600105S, CWS600106S, CWS600107S, CWS600108S, CWS600109S, CWS600110S, CWS600112S, CWS600113S, CWS600114S, CWS600115S, CWS600116S, CWS600118S, CWS600120S, CWS600121S, CWS600123S, CWS600124S, CWS600125S, CWS600126S, CWS600127S and 475 more |
| Model numbers | DDME3D1 |
Product
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; 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-1719-2023. 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.