Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide - Worldwide Distribution Quantity: 7921 units Lot/code info: 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, BLW606952S, BLW607639S, BLW607640S, BLW607209S, BLW607230S, BLW607859S, BLW607300S, BLW606991S, BLW607037S, BLW607252S, BLW607468S, BLW607477S, BLW607513S, BLW607863S, BLW607927S, BLW607946S, BLW607188S, BLW607268S, BLW607360S, BLW607412S, BLW607478S, BLW607602S, BLW607679S, BLW608772S, BLW609755S, BLW607064S, BLW607428S, BLW607613S, BLW607055S, BLW607169S, BLW606979S, BLW606932S, BLW606963S, BLW607041S, BLW607099S, BLW607104S, BLW607274S, BLW607275S, BLW607616S, BLW607617S, BLW607723S, BLW6078

UPC codes

00643169720367, 00643169980129

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.