FDA Device recall Z-1758-2023
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4 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-1758-2023 |
| 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 DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD60…GTIN 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S |
|---|
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-1758-2023%22
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