Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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: 522 units Lot/code info: GTIN 00643169720374, Lot Serial Numbers: BWB231977H, BWB232204H, BWB231981H, BWB231888H, BWB232232H, BWB232076H, BWB231876H, BWB231908H, BWB231979H, BWB232244H, BWB232310H, BWB231918H, BWB232114H, BWB231867H, BWB232361H, BWB231879H, BWB231847H, BWB232311H, BWB232048H, BWB231915H, BWB232272H, BWB232281H, BWB232164H, BWB232142H, BWB232316H, BWB232027H, BWB232321H, BWB231976H, BWB232046H, BWB232357H, BWB232185H, BWB232233H, BWB232334H, BWB232378H, BWB232411H, BWB232049H, BWB232218H, BWB232097H, BWB232326H, BWB232156H, BWB231855H, BWB231858H, BWB232032H, BWB232106H, BWB232015H, BWB232260H, BWB232284H, BWB232328H, BWB232059H, BWB232018H, BWB232037H, BWB232043H, BWB232092H, BWB232112H, BWB232125H, BWB232144H, BWB232175H, BWB232179H, BWB232181H, BWB232190H, BWB232216H, BWB232237H, BWB232340H, BWB232369H, BWB232410H, BWB232414H, BWB231927H, BWB232056H, BWB232071H, BWB232087H, BWB232121H, BWB232250H, BWB232403H, BWB232039H, BWB232123H, BWB232124H, BWB231865H, BWB232128H, BWB232152H, BWB231939H, BWB231999H, BWB232050H, BWB232217H, BWB232298H, BWB232368H, BWB232395H, BWB232222H, BWB232174H, BWB231916H, BWB231963H, BWB231965H, BWB231968H, BWB232084H, BWB232154H, BWB232320H, BWB232393H, BWB232396H, BWB232399H, BWB232400H, BWB232402H, BWB232413H, BWB232243H, BWB232322H, BWB231473H, BWB232183H, BWB232247H, BWB231989H, BWB232256H, BWB232132H, BWB232273H, BWB232274H, BWB232283H, BWB231932H, BWB232089H, BWB232208H, BWB231875H, BWB232269H, BWB232367H, BWB232407H, BWB232065H, BWB232069H, BWB2319

UPC codes

00643169720374, 00763000059699

Source

Official record: FDA (Device enforcement) ↗

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