FDA Device recall Z-1752-2023
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ 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-1752-2023 |
| 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 DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX61…GTIN 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX611227S, BLX610459S, BLX613336S, BLX611231S, BLX610972S, BLX610821S, BLX611566S, BLX611238S, BLX610596S, BLX610449S, BLX610925S, BLX611306S, BLX610523S, BLX611147S, BLX611439S, BLX610568S, BLX611464S, BLX611546S, BLX611733S, BLX611813S, BLX612082S, BLX612083S, BLX612440S, BLX611069S, BLX611190S, BLX611293S, BLX610441S, BLX611452S, BLX610586S, BLX610739S, BLX611422S, BLX610467S, BLX610671S, BLX611002S, BLX611400S, BLX611499S, BLX611540S, BLX611542S, BLX611554S, BLX611561S, BLX611732S, BLX610299S, BLX611218S, BLX611398S, BLX611547S, BLX611549S, BLX611565S, BLX611613S, BLX610991S, BLX611110S, BLX611987S, BLX610490S, BLX611737S, BLX610446S, BLX610447S, BLX611511S, BLX611605S, BLX610480S, BLX611940S, BLX611927S, BLX610329S, BLX610451S, BLX610464S, BLX610989S, BLX611220S, BLX611515S, BLX611564S, BLX611611S, BLX611742S, BLX611923S, BLX610854S, BLX611391S, BLX611392S, BLX611931S |
|---|
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-1752-2023%22
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