CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1 — Class I medical device recall Z-1767-2023
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-1767-2023 |
|---|---|
| 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 | 4,767 units |
| UPC / GTIN / UDI-DI | 00643169837638, 00763000206253 |
| Serial numbers | RPP600541S, RPP600542S, RPP600543S, RPP600595S, RPP600598S, RPP600599S, RPP600600S, RPP600601S, RPP600602S, RPP600603S, RPP600604S, RPP600605S, RPP600606S, RPP600607S, RPP600608S, RPP600609S, RPP600611S, RPP600612S, RPP600613S, RPP600614S, RPP600615S, RPP600616S, RPP600617S, RPP600618S, RPP600619S and 475 more |
| Model numbers | DTMB2Q1 |
Product
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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-1767-2023. 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.