Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; 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: 289 units Lot/code info: GTIN 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S, EVS600568S, EVS600534S, EVS600285S, EVS600288S, EVS600569S, EVS600570S, EVS600638S, EVS600639S, EVS600640S, EVS600393S, EVS600418S, EVS600385S, EVS600015S, EVS600016S, EVS600027S, EVS600517S, EVS600011S, EVS600012S, EVS600013S, EVS600420S, EVS600421S, EVS600014S, EVS6000

UPC codes

00763000217891, 00763000217907

Source

Official record: FDA (Device enforcement) ↗

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