FDA Device recall Z-1748-2023
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ 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-1748-2023 |
| 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 DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; 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 00643169720176, Lot Serial Numbers: BLP603514S, BLP603579S, BLP603583S, BLP603637S, BLP603643S, BLP603554S, BLP60…GTIN 00643169720176, Lot Serial Numbers: BLP603514S, BLP603579S, BLP603583S, BLP603637S, BLP603643S, BLP603554S, BLP603588S, BLP603580S, BLP603582S, BLP603584S, BLP603585S, BLP603586S, BLP603591S, BLP603531S, BLP603552S, BLP603511S, BLP603647S, BLP603581S, BLP603545S, BLP603551S, BLP603569S, BLP603648S, BLP603808S, BLP603536S, BLP603538S, BLP603542S, BLP603543S, BLP603544S, BLP603546S, BLP603549S, BLP603550S, BLP603553S, BLP603555S, BLP603557S, BLP603558S, BLP603562S, BLP603563S, BLP603576S, BLP603577S, BLP603587S, BLP603641S, BLP603670S, BLP603671S, BLP603672S, BLP603673S, BLP603674S, BLP603675S, BLP603676S, BLP603677S, BLP603678S, BLP603729S, BLP603730S, BLP603732S, BLP603733S, BLP603734S, BLP603735S, BLP603736S, BLP603409S, BLP603529S, BLP603533S, BLP603666S, BLP603689S, BLP603716S, BLP603758S, BLP603762S, BLP603786S, BLP603794S, BLP603795S, BLP603798S, BLP603801S, BLP603804S, BLP603807S, BLP603626S, BLP603627S, BLP603628S, BLP603629S, BLP603630S, BLP603631S, BLP603632S, BLP603633S |
|---|
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-1748-2023%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.