FDA Device recall Z-1735-2023
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1 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-1735-2023 |
| 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 DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ62…GTIN 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ624144S, BLJ622126S, BLJ624009S, BLJ622569S, BLJ623322S, BLJ622064S, BLJ622092S, BLJ623468S, BLJ623621S, BLJ623849S, BLJ624135S, BLJ622023S, BLJ623580S, BLJ624033S, BLJ623167S, BLJ623490S, BLJ622292S, BLJ622241S, BLJ623462S, BLJ623794S, BLJ623809S, BLJ624193S, BLJ621886S, BLJ621947S, BLJ622884S, BLJ623297S, BLJ623410S, BLJ623471S, BLJ624039S, BLJ621718S, BLJ622266S, BLJ622481S, BLJ622566S, BLJ622575S, BLJ622578S, BLJ622582S, BLJ622596S, BLJ622621S, BLJ622732S, BLJ622903S, BLJ622934S, BLJ622973S, BLJ623089S, BLJ623300S, BLJ623319S, BLJ623411S, BLJ623413S, BLJ623482S, BLJ623605S, BLJ623615S, BLJ623620S, BLJ623631S, BLJ623771S, BLJ623960S, BLJ622066S, BLJ622581S, BLJ623080S, BLJ623147S, BLJ621736S, BLJ621763S, BLJ622067S, BLJ622237S, BLJ622458S, BLJ622007S, BLJ622992S, BLJ623036S, BLJ623110S, BLJ623296S, BLJ623460S, BLJ623578S, BLJ624142S, BLJ622127S, BLJ622277S, BLJ623416S |
|---|
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-1735-2023%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.