FDA Device recall Z-1768-2023
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ 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-1768-2023 |
| 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 DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; 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 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG61…GTIN 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG619130S, RPG623603S, RPG610818S, RPG616992S, RPG619816S, RPG624535S, RPG614089S, RPG619704S, RPG619714S, RPG623002S, RPG624602S, RPG607260S, RPG607434S, RPG607977S, RPG608232S, RPG608831S, RPG609415S, RPG609836S, RPG609911S, RPG610009S, RPG610345S, RPG611061S, RPG611302S, RPG611328S, RPG611598S, RPG611600S, RPG611606S, RPG611666S, RPG611667S, RPG611668S, RPG612610S, RPG612884S, RPG612885S, RPG613206S, RPG613239S, RPG613578S, RPG613655S, RPG614353S, RPG614407S, RPG614439S, RPG614898S, RPG615028S, RPG617792S, RPG617839S, RPG618125S, RPG618648S, RPG618809S, RPG618811S, RPG619226S, RPG619228S, RPG619555S, RPG619776S, RPG619888S, RPG619890S, RPG619891S, RPG620540S, RPG620563S, RPG621028S, RPG621106S, RPG621190S, RPG621228S, RPG621272S, RPG621395S, RPG621680S, RPG621722S, RPG621724S, RPG621725S, RPG621730S, RPG621743S, RPG622038S, RPG622041S, RPG622085S, RPG622532S, RPG622533S |
|---|
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-1768-2023%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.