FDA Device recall Z-1732-2023
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1 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-1732-2023 |
| 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 DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; 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 00643169720190, Lot Serial Numbers: BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD21…GTIN 00643169720190, Lot Serial Numbers: BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H |
|---|
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-1732-2023%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.