FDA Device recall Z-1760-2023
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ 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-1760-2023 |
| 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 DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB61…GTIN 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S |
|---|
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-1760-2023%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.