Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; 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: 5622 units Lot/code info: GTIN 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ601914S, CWJ603587S, CWJ603802S, CWJ601000S, CWJ601001S, CWJ601158S, CWJ601706S, CWJ601799S, CWJ601845S, CWJ604343S, CWJ604387S, CWJ601910S, CWJ603379S, CWJ603449S, CWJ603454S, CWJ603109S, CWJ603385S, CWJ603717S, CWJ604036S, CWJ604043S, CWJ604092S, CWJ604118S, CWJ604397S, CWJ603165S, CWJ603501S, CWJ603684S, CWJ603685S, CWJ603693S, CWJ603831S, CWJ604218S, CWJ604314S, CWJ604338S, CWJ601875S, CWJ601903S, CWJ603686S, CWJ603836S, CWJ603869S, CWJ603875S, CWJ604377S, CWJ601894S, CWJ601905S, CWJ601909S, CWJ603429S, CWJ603660S, CWJ603060S, CWJ603731S, CWJ603760S, CWJ604336S, CWJ604355S, CWJ603859S, CWJ603697S, CWJ603700S, CWJ603849S, CWJ604337S, CWJ603687S, CWJ603695S, CWJ601906S, CWJ603445S, CWJ603873S, CWJ604179S, CWJ603842S, CWJ604042S, CWJ604094S, CWJ604339S, CWJ604358S, CWJ604117S, CWJ601891S, CWJ602956S, CWJ603275S, CWJ604684S, CWJ603881S, CWJ603884S, CWJ603939S, CWJ603957S, CWJ604167S, CWJ604178S, CWJ600977S, CWJ601408S, CWJ601788S, CWJ602434S, CWJ602745S, CWJ602880S, CWJ603241S, CWJ603297S, CWJ604580S, CWJ602700S, CWJ603061S, CWJ603107S, CWJ600881S, CWJ601208S, CWJ601611S, CWJ602039S, CWJ602115S, CWJ602503S, CWJ603723S, CWJ600971S, CWJ600974S, CWJ601067S, CWJ602190S, CWJ601175S, CWJ602150S, CWJ601675S, CWJ601315S, CWJ601498S, CWJ601661S, CWJ601714S, CWJ603486S, CWJ603828S, CWJ601669S, CWJ601686S, CWJ601724S, CWJ601911S, CWJ602067S, CWJ602106S, CWJ602168S, CWJ6021

UPC codes

00643169837812

Source

Official record: FDA (Device enforcement) ↗

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