CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 — Class I medical device recall Z-1760-2023
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-1760-2023 |
|---|---|
| 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 | 23,223 units |
| UPC / GTIN / UDI-DI | 00643169720640, 00763000008345, 00763000206222 |
| Serial numbers | 55S, RPB603655S, RPB603656S, RPB603661S, RPB603678S, RPB603679S, RPB603683S, RPB603688S, RPB603689S, RPB603697S, RPB603706S, RPB603735S, RPB603737S, RPB603739S, RPB603754S, RPB603755S, RPB603769S, RPB603776S, RPB603777S, RPB603778S, RPB603780S, RPB603787S, RPB603789S, RPB603795S, RPB603796S and 475 more |
| Model numbers | DTMA2QQ |
Product
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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-1760-2023. 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.