Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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: 2931 units Lot/code info: GTIN 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG625193S, BLG625324S, BLG625325S, BLG625434S, BLG625596S, BLG625598S, BLG625606S, BLG625608S, BLG625636S, BLG625647S, BLG625702S, BLG625740S, BLG625741S, BLG625745S, BLG625962S, BLG626105S, BLG626141S, BLG624936S, BLG624987S, BLG624995S, BLG625164S, BLG625167S, BLG625168S, BLG625242S, BLG625247S, BLG625565S, BLG625566S, BLG625568S, BLG625573S, BLG625616S, BLG625619S, BLG625620S, BLG625624S, BLG625651S, BLG625653S, BLG625655S, BLG625656S, BLG625489S, BLG625612S, BLG625910S, BLG624312S, BLG625331S, BLG624790S, BLG624843S, BLG624880S, BLG624881S, BLG624878S, BLG625644S, BLG624773S, BLG625148S, BLG625224S, BLG624958S, BLG625000S, BLG624751S, BLG624884S, BLG624890S, BLG624895S, BLG624896S, BLG624901S, BLG625171S, BLG625173S, BLG625175S, BLG625197S, BLG625571S, BLG625597S, BLG625605S, BLG625626S, BLG625630S, BLG625705S, BLG625876S, BLG626149S, BLG625650S, BLG625631S, BLG625228S, BLG625243S, BLG624759S, BLG625953S, BLG624816S, BLG624819S, BLG624827S, BLG624863S, BLG624889S, BLG624792S, BLG624795S, BLG625013S, BLG625023S, BLG625025S, BLG625304S, BLG625308S, BLG625311S, BLG625312S, BLG625317S, BLG625318S, BLG625319S, BLG625320S, BLG625321S, BLG625323S, BLG625241S, BLG624874S, BLG625239S, BLG625225S, BLG624879S, BLG625220S, BLG624947S, BLG624952S, BLG624954S, BLG625001S, BLG625652S, BLG624750S, BLG624754S, BLG624761S, BLG624762S, BLG624763S, BLG624765S, BLG625189S, BLG6253

UPC codes

00643169720169, 00643169980143

Source

Official record: FDA (Device enforcement) ↗

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