FDA Device recall Z-1737-2023
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4 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-1737-2023 |
| 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 DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI61…GTIN 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S |
|---|
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-1737-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.