FDA Device recall Z-1772-2023
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4 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-1772-2023 |
| 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 DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; 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 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH60…GTIN 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH606758S, RPH603572S, RPH606941S, RPH603152S, RPH603203S, RPH603999S, RPH604021S, RPH606976S, RPH603841S, RPH604928S, RPH605779S, RPH605780S, RPH606559S, RPH606577S, RPH606694S, RPH606731S, RPH606795S, RPH607014S, RPH607015S, RPH607016S, RPH607157S, RPH607244S, RPH607443S, RPH607748S, RPH608114S, RPH607674S, RPH607675S, RPH607677S, RPH607681S, RPH607688S, RPH609399S, RPH607884S, RPH608003S, RPH608138S, RPH608464S, RPH608655S, RPH608676S, RPH608835S, RPH608853S, RPH608950S, RPH608952S, RPH608958S, RPH609021S, RPH609279S, RPH609280S, RPH609281S, RPH609282S, RPH607432S, RPH609308S, RPH607753S, RPH603849S, RPH603912S, RPH603913S, RPH604139S, RPH604140S, RPH604142S, RPH604266S, RPH604267S, RPH604268S, RPH604435S, RPH604692S, RPH604708S, RPH604785S, RPH605048S, RPH605058S, RPH605167S, RPH605790S, RPH605824S, RPH605882S, RPH606393S, RPH606447S, RPH606491S, RPH606568S, RPH607305S |
|---|
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-1772-2023%22
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