Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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: 6477 units Lot/code info: GTIN 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S, PLZ613227S, PLZ613228S, PLZ610496S, PLZ611729S, PLZ613235S, PLZ613279S, PLZ613296S, PLZ610318S, PLZ610326S, PLZ610352S, PLZ610458S, PLZ610459S, PLZ611004S, PLZ611730S, PLZ611922S, PLZ612232S, PLZ612654S, PLZ612815S, PLZ613229S, PLZ613230S, PLZ613238S, PLZ613239S, PLZ613244S, PLZ613245S, PLZ613265S, PLZ613271S, PLZ613274S, PLZ613275S, PLZ613276S, PLZ613283S, PLZ613285S, PLZ613287S, PLZ613293S, PLZ613294S, PLZ613309S, PLZ613291S, PLZ610995S, PLZ611747S, PLZ611748S, PLZ611920S, PLZ611921S, PLZ6132

UPC codes

00643169720565, 00643169720572

Source

Official record: FDA (Device enforcement) ↗

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