Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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: 1132 units Lot/code info: GTIN 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH605674S, BLH605156S, BLH605237S, BLH605376S, BLH605837S, BLH605887S, BLH605736S, BLH605691S, BLH605953S, BLH604859S, BLH605700S, BLH605904S, BLH605933S, BLH605945S, BLH605854S, BLH605929S, BLH605742S, BLH605709S, BLH605877S, BLH605786S, BLH605711S, BLH605574S, BLH605747S, BLH605932S, BLH604888S, BLH605014S, BLH605399S, BLH605699S, BLH605705S, BLH605729S, BLH605732S, BLH605806S, BLH605239S, BLH605233S, BLH605704S, BLH605730S, BLH605821S, BLH605400S, BLH605011S, BLH605850S, BLH605707S, BLH605241S, BLH605819S, BLH605820S, BLH605577S, BLH605235S, BLH604907S, BLH605676S, BLH605915S, BLH605319S, BLH605582S, BLH605391S, BLH605519S, BLH605589S, BLH605741S, BLH604904S, BLH605738S, BLH605835S, BLH605845S, BLH605846S, BLH605823S, BLH604886S, BLH605151S, BLH605398S, BLH605702S, BLH605591S, BLH605394S, BLH605672S, BLH605726S, BLH605581S, BLH605790S, BLH605397S, BLH605791S, BLH605690S, BLH605708S, BLH604902S, BLH605157S, BLH605733S, BLH605861S, BLH605584S, BLH605746S, BLH605145S, BLH604878S, BLH605719S, BLH605232S, BLH605269S, BLH605826S, BLH605737S, BLH605871S, BLH605373S, BLH605739S, BLH605388S, BLH605585S, BLH605587S, BLH605780S, BLH605728S, BLH604894S, BLH605782S, BLH605706S, BLH604879S, BLH605701S, BLH605694S, BLH605758S, BLH605012S, BLH605393S, BLH605696S, BLH605940S, BLH605695S, BLH604893S, BLH605753S; GTIN 00643169720220, Lot Serial Numbers: BLH605473S, BLH604935S, BL

UPC codes

00643169400603, 00643169720220, 00643169980174

Source

Official record: FDA (Device enforcement) ↗

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