Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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: 25058 Lot/code info: GTIN 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ616311S, PMZ616317S, PMZ616329S, PMZ614015S, PMZ614036S, PMZ616320S, PMZ613982S, PMZ615518S, PMZ616318S, PMZ616327S, PMZ618780S, PMZ618807S, PMZ618813S, PMZ616312S, PMZ616323S, PMZ618796S, PMZ619084S, PMZ618785S, PMZ616326S, PMZ618798S, PMZ614044S, PMZ612017S, PMZ612853S, PMZ613328S, PMZ613097S, PMZ614065S, PMZ614046S, PMZ613063S, PMZ613316S, PMZ614003S, PMZ614010S, PMZ614033S, PMZ614097S, PMZ613087S, PMZ613201S, PMZ614058S, PMZ614099S, PMZ613212S, PMZ613219S, PMZ613207S, PMZ613206S, PMZ613318S, PMZ613962S, PMZ614002S, PMZ613216S, PMZ613313S, PMZ613073S, PMZ613077S, PMZ613079S, PMZ613082S, PMZ613998S, PMZ613999S, PMZ614000S, PMZ614083S, PMZ614085S, PMZ614087S, PMZ614092S, PMZ614093S, PMZ613078S, PMZ614042S, PMZ613189S, PMZ613098S, PMZ613071S, PMZ613891S, PMZ613892S, PMZ613893S, PMZ613894S, PMZ613895S, PMZ614024S, PMZ614026S, PMZ614027S, PMZ614028S, PMZ614029S, PMZ614060S, PMZ614094S, PMZ615795S, PMZ614012S, PMZ614014S, PMZ614034S, PMZ613069S, PMZ614021S, PMZ614025S, PMZ614055S, PMZ613881S, PMZ614030S, PMZ614095S, PMZ613976S, PMZ613977S, PMZ614062S, PMZ614071S, PMZ613322S, PMZ613033S, PMZ613034S, PMZ613995S, PMZ613996S, PMZ614008S, PMZ614032S, PMZ614038S, PMZ614039S, PMZ613036S, PMZ613314S, PMZ613878S, PMZ613978S, PMZ614022S, PMZ613086S, PMZ614006S, PMZ614056S, PMZ613985S, PMZ614004S, PMZ614013S, PMZ614019S, PMZ614031S, PMZ613979S, PMZ613987S, PMZ613085S, PMZ6131

UPC codes

00643169720596, 00643169720602

Source

Official record: FDA (Device enforcement) ↗

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