Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; 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: 240 units Lot/code info: GTIN 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H, BWP202381H, BWP202303H, BWP202223H, BWP202409H, BWP202249H, BWP202173H, BWP202158H, BWP202635H, BWP202415H, BWP202438H, BWP202177H, BWP202315H, BWP202360H, BWP202372H, BWP202388H, BWP202451H, BWP202498H, BWP202500H, BWP202504H, BWP202507H, BWP202515H, BWP202525H, BWP2025

UPC codes

00643169720626

Source

Official record: FDA (Device enforcement) ↗

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