FDA Device recall Z-1739-2023
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ 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-1739-2023 |
| 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 DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG62…GTIN 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG625193S, BLG625324S, BLG625325S, BLG625434S, BLG625596S, BLG625598S, BLG625606S, BLG625608S, BLG625636S, BLG625647S, BLG625702S, BLG625740S, BLG625741S, BLG625745S, BLG625962S, BLG626105S, BLG626141S, BLG624936S, BLG624987S, BLG624995S, BLG625164S, BLG625167S, BLG625168S, BLG625242S, BLG625247S, BLG625565S, BLG625566S, BLG625568S, BLG625573S, BLG625616S, BLG625619S, BLG625620S, BLG625624S, BLG625651S, BLG625653S, BLG625655S, BLG625656S, BLG625489S, BLG625612S, BLG625910S, BLG624312S, BLG625331S, BLG624790S, BLG624843S, BLG624880S, BLG624881S, BLG624878S, BLG625644S, BLG624773S, BLG625148S, BLG625224S, BLG624958S, BLG625000S, BLG624751S, BLG624884S, BLG624890S, BLG624895S, BLG624896S, BLG624901S, BLG625171S, BLG625173S, BLG625175S, BLG625197S, BLG625571S, BLG625597S, BLG625605S, BLG625626S, BLG625630S, BLG625705S, BLG625876S, BLG626149S, BLG625650S, BLG625631S, BLG625228S |
|---|
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-1739-2023%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.