FDA Device recall Z-1733-2023
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ 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-1733-2023 |
| 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 DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC22…GTIN 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, BLC228296H, BLC228583H, BLC228787H, BLC228926H, BLC229106H, BLC228579H, BLC228245H, BLC228551H, BLC228625H, BLC228819H, BLC228440H, BLC228622H, BLC228825H, BLC228456H, BLC228432H, BLC228960H, BLC229166H, BLC228545H, BLC228676H, BLC228695H, BLC228573H, BLC229089H, BLC228721H, BLC228898H, BLC228980H, BLC229099H, BLC228302H, BLC228256H, BLC228258H, BLC228300H, BLC228319H, BLC228355H, BLC228394H, BLC228406H, BLC228450H, BLC228461H, BLC228515H, BLC228309H, BLC228379H, BLC228491H, BLC228510H, BLC228511H, BLC228577H, BLC228707H, BLC228800H, BLC228861H, BLC229110H, BLC229192H, BLC229207H, BLC229107H, BLC228228H, BLC228312H |
|---|
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-1733-2023%22
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