FDA Device recall Z-1742-2023
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4 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-1742-2023 |
| 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 DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; 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 00643169720268, Lot Serial Numbers: BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN20…GTIN 00643169720268, Lot Serial Numbers: BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN205573H, BLN205101H, BLN205395H, BLN205424H, BLN205448H, BLN205505H, BLN205574H, BLN205579H, BLN205432H, BLN205460H, BLN205545H, BLN205566H, BLN205554H, BLN205583H, BLN205390H, BLN205669H, BLN205438H, BLN205653H, BLN205533H, BLN205387H, BLN205527H, BLN205528H, BLN205571H, BLN205591H, BLN205623H, BLN205485H, BLN205501H, BLN205594H, BLN205618H, BLN205381H, BLN205462H, BLN205684H, BLN205479H, BLN205509H, BLN205627H, BLN205663H, BLN205682H, BLN205382H, BLN205384H, BLN205549H, BLN205557H, BLN205482H, BLN205454H, BLN205548H, BLN205560H, BLN205408H, BLN205521H, BLN205529H, BLN205552H, BLN205491H, BLN205645H, BLN205586H, BLN205480H, BLN205516H, BLN205486H, BLN205520H, BLN205417H, BLN205415H, BLN205558H, BLN205630H, BLN205655H, BLN205458H, BLN205435H, BLN205428H, BLN205555H, BLN205446H, BLN205420H, BLN205481H, BLN205399H, BLN205437H, BLN205459H, BLN205463H, BLN205476H, BLN205477H |
|---|
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-1742-2023%22
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