FDA Device recall Z-1765-2023
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1765-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Reason
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.
Identifiers
| code_info | GTIN 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ60…GTIN 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ605881S, RPQ601451S, RPQ602698S, RPQ605503S, RPQ606300S, RPQ601185S, RPQ601351S, RPQ601948S, RPQ601950S, RPQ602093S, RPQ602202S, RPQ602212S, RPQ602402S, RPQ602403S, RPQ602595S, RPQ602960S, RPQ602961S, RPQ602985S, RPQ603049S, RPQ603082S, RPQ603318S, RPQ603408S, RPQ603450S, RPQ605289S, RPQ606079S, RPQ603112S, RPQ603355S, RPQ603428S, RPQ604101S, RPQ604644S, RPQ602479S, RPQ603775S, RPQ604354S, RPQ604567S, RPQ605754S, RPQ605514S, RPQ605535S, RPQ603729S, RPQ605540S, RPQ603758S, RPQ604571S, RPQ605118S, RPQ602683S, RPQ602692S, RPQ602715S, RPQ603495S, RPQ603504S, RPQ603555S, RPQ603644S, RPQ603647S, RPQ604572S, RPQ604621S, RPQ604622S, RPQ604684S, RPQ604686S, RPQ604777S, RPQ604953S, RPQ605095S, RPQ605164S, RPQ605353S, RPQ605428S, RPQ602526S, RPQ602527S, RPQ602702S, RPQ603503S, RPQ604660S, RPQ604880S, RPQ604892S, RPQ604942S, RPQ604951S, RPQ605209S, RPQ602359S, RPQ602686S, RPQ602740S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1765-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.