FDA Device recall Z-1749-2023
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1 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-1749-2023 |
| 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 DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; 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 00643169720367, Lot Serial Numbers: BLW607464S, BLW607601S, BLW607643S, BLW607705S, BLW607921S, BLW608132S, BLW60…GTIN 00643169720367, Lot Serial Numbers: BLW607464S, BLW607601S, BLW607643S, BLW607705S, BLW607921S, BLW608132S, BLW608133S, BLW608134S, BLW608135S, BLW608235S, BLW608746S, BLW609769S, BLW606989S, BLW607809S, BLW607902S, BLW607917S, BLW607284S, BLW607004S, BLW607851S, BLW607173S, BLW607320S, BLW607015S, BLW607319S, BLW607257S, BLW607269S, BLW607346S, BLW607361S, BLW607031S, BLW607243S, BLW606959S, BLW607058S, BLW607285S, BLW607580S, BLW607394S, BLW607249S, BLW607505S, BLW607573S, BLW606999S, BLW607254S, BLW607835S, BLW607159S, BLW606948S, BLW606961S, BLW607044S, BLW607113S, BLW607292S, BLW607406S, BLW607498S, BLW607661S, BLW607758S, BLW607759S, BLW607865S, BLW607248S, BLW607866S, BLW607021S, BLW607598S, BLW607665S, BLW607823S, BLW607493S, BLW607001S, BLW607817S, BLW607841S, BLW607883S, BLW607747S, BLW608268S, BLW607287S, BLW607356S, BLW607440S, BLW607473S, BLW607636S, BLW607709S, BLW607943S, BLW606941S, BLW607330S, BLW607029S, BLW607205S, BLW607207S, BLW607818S, BLW607896S, BLW607847S |
|---|
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-1749-2023%22
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