FDA Device recall Z-1731-2023
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4 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-1731-2023 |
| 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 DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; 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 00643169720251, Lot Serial Numbers: BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE22…GTIN 00643169720251, Lot Serial Numbers: BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE221190H, BLE221267H, BLE221842H, BLE221265H, BLE221430H, BLE221711H, BLE221346H, BLE221631H, BLE221285H, BLE221405H, BLE221436H, BLE221551H, BLE221411H, BLE221342H, BLE221584H, BLE221694H, BLE221282H, BLE221465H, BLE221191H, BLE221384H, BLE221805H, BLE221309H, BLE221222H, BLE221327H, BLE221548H, BLE221562H, BLE221702H, BLE221450H, BLE221715H, BLE221246H, BLE221654H, BLE221686H, BLE221713H, BLE221750H, BLE221758H, BLE221814H, BLE221828H, BLE221843H, BLE221844H, BLE221851H, BLE221854H, BLE221855H, BLE221861H, BLE221561H, BLE221727H, BLE221751H, BLE221789H, BLE221862H, BLE221670H, BLE221707H, BLE221752H, BLE221849H, BLE221475H, BLE221687H, BLE221601H, BLE221748H, BLE221173H, BLE221336H, BLE221413H, BLE221426H, BLE221580H, BLE221174H, BLE221176H, BLE221759H, BLE221227H, BLE221660H, BLE221334H, BLE221627H, BLE220376H, BLE221338H, BLE221213H, BLE221349H, BLE221658H, BLE221661H |
|---|
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-1731-2023%22
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