FDA Device recall Z-1750-2023
CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4 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-1750-2023 |
| 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 DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ60…GTIN 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ604013S, BLZ604101S, BLZ603725S, BLZ604036S, BLZ604059S, BLZ603770S, BLZ604032S, BLZ603602S, BLZ603626S, BLZ604001S, BLZ603743S, BLZ604536S, BLZ603622S, BLZ604076S, BLZ604915S, BLZ604263S, BLZ603735S, BLZ603422S, BLZ603918S, BLZ604138S, BLZ603587S, BLZ603604S, BLZ603663S, BLZ603723S, BLZ603840S, BLZ604082S, BLZ604065S, BLZ604080S, BLZ604102S, BLZ603740S, BLZ603967S, BLZ604467S, BLZ603620S, BLZ603705S, BLZ603788S, BLZ603812S, BLZ603977S, BLZ603978S, BLZ603980S, BLZ604031S, BLZ604072S, BLZ604134S, BLZ604097S, BLZ603639S, BLZ603941S, BLZ604056S, BLZ603594S, BLZ603683S, BLZ603720S, BLZ603898S, BLZ603921S, BLZ603982S, BLZ603983S, BLZ604057S, BLZ604135S, BLZ604908S, BLZ603732S, BLZ603787S, BLZ604146S, BLZ603643S, BLZ603958S, BLZ604107S, BLZ603796S, BLZ603605S, BLZ603902S, BLZ604049S, BLZ603694S, BLZ604103S, BLZ603716S, BLZ604111S, BLZ604006S, BLZ604110S, BLZ604099S, BLZ603874S |
|---|
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-1750-2023%22
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