Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; 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: 12099 units Lot/code info: GTIN 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG211814H, CWG212178H, CWG208135H, CWG209489H, CWG209599H, CWG212702H, CWG214349H, CWG214379H, CWG206584H, CWG208347H, CWG206776H, CWG206895H, CWG211478H, CWG211709H, CWG212079H, CWG212183H, CWG212836H, CWG205283H, CWG205284H, CWG205288H, CWG207805H, CWG207808H, CWG207809H, CWG207810H, CWG207811H, CWG207812H, CWG208949H, CWG209030H, CWG209031H, CWG209285H, CWG209646H, CWG209659H, CWG209823H, CWG210928H, CWG210929H, CWG211866H, CWG212840H, CWG212841H, CWG212842H, CWG212843H, CWG212844H, CWG212846H, CWG212847H, CWG212851H, CWG212853H, CWG212854H, CWG213620H, CWG213622H, CWG213623H, CWG206242H, CWG206868H, CWG209799H, CWG212914H, CWG205298H, CWG205299H, CWG205450H, CWG205777H, CWG206838H, CWG206972H, CWG208335H, CWG208502H, CWG209280H, CWG209978H, CWG209979H, CWG209981H, CWG209982H, CWG209983H, CWG211070H, CWG211071H, CWG211072H, CWG211696H, CWG212566H, CWG212568H, CWG212569H, CWG213285H, CWG213505H, CWG213756H, CWG214277H, CWG214324H, CWG204936H, CWG205368H, CWG206168H, CWG208188H, CWG208467H, CWG213778H, CWG206589H, CWG206593H, CWG209988H, CWG210659H, CWG213726H, CWG213727H, CWG213728H, CWG208549H, CWG213157H, CWG206078H, CWG206763H, CWG207072H, CWG207829H, CWG207979H, CWG209086H, CWG209271H, CWG209763H, CWG211506H, CWG213628H, CWG214299H, CWG206015H, CWG206115H, CWG206347H, CWG206398H, CWG206864H, CWG207060H, CWG207230H, CWG208431H, CWG208825H, CWG208869H, CWG2095

UPC codes

00643169837799

Source

Official record: FDA (Device enforcement) ↗

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