FDA Device recall Z-1738-2023
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1 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-1738-2023 |
| 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 DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH60…GTIN 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH605674S, BLH605156S, BLH605237S, BLH605376S, BLH605837S, BLH605887S, BLH605736S, BLH605691S, BLH605953S, BLH604859S, BLH605700S, BLH605904S, BLH605933S, BLH605945S, BLH605854S, BLH605929S, BLH605742S, BLH605709S, BLH605877S, BLH605786S, BLH605711S, BLH605574S, BLH605747S, BLH605932S, BLH604888S, BLH605014S, BLH605399S, BLH605699S, BLH605705S, BLH605729S, BLH605732S, BLH605806S, BLH605239S, BLH605233S, BLH605704S, BLH605730S, BLH605821S, BLH605400S, BLH605011S, BLH605850S, BLH605707S, BLH605241S, BLH605819S, BLH605820S, BLH605577S, BLH605235S, BLH604907S, BLH605676S, BLH605915S, BLH605319S, BLH605582S, BLH605391S, BLH605519S, BLH605589S, BLH605741S, BLH604904S, BLH605738S, BLH605835S, BLH605845S, BLH605846S, BLH605823S, BLH604886S, BLH605151S, BLH605398S, BLH605702S, BLH605591S, BLH605394S, BLH605672S, BLH605726S, BLH605581S, BLH605790S, BLH605397S, BLH605791S, BLH605690S |
|---|
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-1738-2023%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.