Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; 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: 15381 units Lot/code info: GTIN 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, PLX606748S, PLX610920S, PLX614233S, PLX607508S, PLX612649S, PLX612650S, PLX608980S, PLX609862S, PLX604556S, PLX610980S, PLX607566S, PLX608469S, PLX610900S, PLX606141S, PLX608096S, PLX608113S, PLX609491S, PLX609859S, PLX611893S, PLX611897S, PLX608092S, PLX607939S, PLX608401S, PLX608994S, PLX606341S, PLX609486S, PLX608954S, PLX604652S, PLX605335S, PLX605336S, PLX606958S, PLX610935S, PLX612860S, PLX609834S, PLX607784S, PLX607327S, PLX607665S, PLX609533S, PLX610317S, PLX611000S, PLX614302S, PLX605298S, PLX608179S, PLX606993S, PLX607676S, PLX609003S, PLX609006S, PLX609529S, PLX612993S, PLX607312S, PLX610951S, PLX611042S, PLX608106S, PLX609230S, PLX610912S, PLX611002S, PLX609875S, PLX612480S, PLX6081

UPC codes

00643169717992, 00643169720800

Source

Official record: FDA (Device enforcement) ↗

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