FDA Device recall Z-1751-2023
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1 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-1751-2023 |
| 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 DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY60…GTIN 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY602563S, BLY602693S, BLY602474S, BLY602424S, BLY602465S, BLY602812S, BLY602676S, BLY602445S, BLY602572S, BLY602497S, BLY602549S, BLY602715S, BLY602735S, BLY602531S, BLY602657S, BLY603005S, BLY602489S, BLY602628S, BLY602652S, BLY602459S, BLY602483S, BLY602576S, BLY602450S, BLY602521S, BLY602574S, BLY602680S, BLY602386S, BLY602463S, BLY602694S, BLY602747S, BLY602449S, BLY602401S, BLY602413S, BLY602432S, BLY602631S, BLY602633S, BLY602672S, BLY602740S, BLY602741S, BLY602403S, BLY602412S, BLY602517S, BLY602528S, BLY602430S, BLY602501S, BLY602270S, BLY602552S, BLY602713S, BLY602478S, BLY602543S, BLY602443S, BLY602464S, BLY602634S, BLY602421S, BLY602564S, BLY602462S, BLY602525S, BLY602673S, BLY602717S, BLY602734S, BLY602467S, BLY602487S, BLY602377S, BLY602682S, BLY602712S, BLY602423S, BLY602659S, BLY602725S, BLY602393S, BLY602524S, BLY602565S, BLY602630S, BLY602378S, BLY602696S |
|---|
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-1751-2023%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.