FDA Device recall Z-1759-2023
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1 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-1759-2023 |
| 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 DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; 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 00643169837614, Lot Serial numbers: RPN602297S, RPN602079S, RPN601385S, RPN601320S, RPN601216S, RPN601977S, RPN60…GTIN 00643169837614, Lot Serial numbers: RPN602297S, RPN602079S, RPN601385S, RPN601320S, RPN601216S, RPN601977S, RPN602107S, RPN600885S, RPN601199S, RPN600682S, RPN601504S, RPN601513S, RPN601653S, RPN601681S, RPN602258S, RPN600961S, RPN600858S, RPN600867S, RPN600868S, RPN600942S, RPN601384S, RPN601398S, RPN601516S, RPN601873S, RPN601874S, RPN602264S, RPN602302S, RPN602350S, RPN602422S, RPN602462S, RPN602468S, RPN602507S, RPN601042S, RPN601529S, RPN602434S, RPN601306S, RPN601439S, RPN602416S, RPN601214S, RPN601763S, RPN601891S, RPN600750S, RPN601165S, RPN600770S, RPN601245S, RPN602186S, RPN602293S, RPN600666S, RPN600683S, RPN601094S, RPN601229S, RPN601277S, RPN601298S, RPN601393S, RPN601662S, RPN602160S, RPN600812S, RPN601674S, RPN602429S, RPN600678S, RPN602335S, RPN602420S, RPN601154S, RPN601660S, RPN602247S, RPN602355S, RPN602463S, RPN600888S, RPN601753S, RPN601619S, RPN600829S, RPN601839S, RPN601845S, RPN602501S, RPN602393S, RPN600717S, RPN600808S, RPN602021S, RPN602251S, RPN602415S |
|---|
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-1759-2023%22
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