FDA Device recall Z-1744-2023
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ 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-1744-2023 |
| 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
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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 00643169720145, Lot Serial Numbers: BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK20…GTIN 00643169720145, Lot Serial Numbers: BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H |
|---|
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-1744-2023%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.