Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; 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: 5296 units Lot/code info: GTIN 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL206087H, BWL205882H, BWL206049H, BWL206050H, BWL206053H, BWL206055H, BWL206059H, BWL206069H, BWL206073H, BWL206074H, BWL206078H, BWL206079H, BWL206081H, BWL206082H, BWL206083H, BWL206084H, BWL206101H, BWL206104H, BWL206110H, BWL206112H, BWL206116H, BWL206118H, BWL206120H, BWL206122H, BWL206123H, BWL206126H, BWL206127H, BWL206068H, BWL206071H, BWL206092H, BWL206093H, BWL206094H, BWL206109H, BWL206117H, BWL206119H, BWL206097H, BWL205878H, BWL206098H, BWL206063H, BWL206114H, BWL206108H, BWL206048H, BWL206064H, BWL206058H, BWL206086H, BWL206099H, BWL206076H, BWL206103H, BWL206107H, BWL206124H, BWL206125H, BWL206105H, BWL206051H, BWL206054H; GTIN 00643169720459, Lot Serial Numbers: BWL606762S, BWL606799S, BWL609508S, BWL606741S, BWL607597S, BWL607510S, BWL607234S, BWL606748S, BWL607162S, BWL607513S, BWL607947S, BWL606791S, BWL607876S, BWL606995S, BWL607071S, BWL606857S, BWL606752S, BWL607088S, BWL606806S, BWL606900S, BWL606908S, BWL606738S, BWL606758S, BWL606759S, BWL607084S, BWL607199S, BWL607220S, BWL607277S, BWL607512S, BWL607519S, BWL607558S, BWL607571S, BWL607805S, BWL607806S, BWL609503S, BWL609505S, BWL609506S, BWL606452S, BWL606742S, BWL606743S, BWL606751S, BWL606757S, BWL606766S, BWL606767S, BWL606805S, BWL606840S, BWL606899S, BWL606942S, BWL607001S, BWL607013S, BWL607074S, BWL607215S, BWL607423S, BWL607542S, BWL607590S, BWL607593S, BWL607594S, BWL607613S, BW

UPC codes

00643169720442, 00643169720459, 00643169980273

Source

Official record: FDA (Device enforcement) ↗

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