FDA Device recall Z-1729-2023
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1 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-1729-2023 |
| 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 DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; 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 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF25…GTIN 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF257081H, BLF257089H, BLF257260H, BLF257290H, BLF257410H, BLF257440H, BLF257565H, BLF257668H, BLF257684H, BLF257873H, BLF257966H, BLF256897H, BLF257648H, BLF256756H, BLF256776H, BLF256865H, BLF257835H, BLF257086H, BLF257198H, BLF257413H, BLF257605H, BLF257611H, BLF257863H, BLF257960H, BLF257342H, BLF257460H, BLF257657H, BLF256948H, BLF257877H, BLF256848H, BLF257404H, BLF257931H, BLF257961H, BLF258043H, BLF258080H, BLF257904H, BLF257104H, BLF257029H, BLF257408H, BLF257431H, BLF257388H, BLF257618H, BLF257916H, BLF257972H, BLF256843H, BLF256844H, BLF256971H, BLF257125H, BLF257347H, BLF258090H, BLF257677H, BLF258051H, BLF257844H, BLF257627H, BLF257348H, BLF258261H, BLF257215H, BLF257468H, BLF256758H, BLF257803H, BLF258143H, BLF257449H, BLF257885H, BLF257899H, BLF257956H, BLF258078H, BLF258093H, BLF258094H, BLF258178H, BLF258228H, BLF257037H, BLF257384H, BLF258292H, BLF257430H |
|---|
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-1729-2023%22
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