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.
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: 28172 units Lot/code info: GTIN 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG619130S, RPG623603S, RPG610818S, RPG616992S, RPG619816S, RPG624535S, RPG614089S, RPG619704S, RPG619714S, RPG623002S, RPG624602S, RPG607260S, RPG607434S, RPG607977S, RPG608232S, RPG608831S, RPG609415S, RPG609836S, RPG609911S, RPG610009S, RPG610345S, RPG611061S, RPG611302S, RPG611328S, RPG611598S, RPG611600S, RPG611606S, RPG611666S, RPG611667S, RPG611668S, RPG612610S, RPG612884S, RPG612885S, RPG613206S, RPG613239S, RPG613578S, RPG613655S, RPG614353S, RPG614407S, RPG614439S, RPG614898S, RPG615028S, RPG617792S, RPG617839S, RPG618125S, RPG618648S, RPG618809S, RPG618811S, RPG619226S, RPG619228S, RPG619555S, RPG619776S, RPG619888S, RPG619890S, RPG619891S, RPG620540S, RPG620563S, RPG621028S, RPG621106S, RPG621190S, RPG621228S, RPG621272S, RPG621395S, RPG621680S, RPG621722S, RPG621724S, RPG621725S, RPG621730S, RPG621743S, RPG622038S, RPG622041S, RPG622085S, RPG622532S, RPG622533S, RPG622881S, RPG622905S, RPG622984S, RPG623287S, RPG623393S, RPG623681S, RPG623684S, RPG623693S, RPG624227S, RPG624640S, RPG624641S, RPG624699S, RPG624702S, RPG625103S, RPG625298S, RPG625299S, RPG625307S, RPG625310S, RPG625343S, RPG625704S, RPG625915S, RPG625919S, RPG626152S, RPG626157S, RPG626198S, RPG626210S, RPG626396S, RPG626399S, RPG626402S, RPG626560S, RPG626605S, RPG626606S, RPG618474S, RPG618477S, RPG618499S, RPG618602S, RPG618603S, RPG618611S, RPG618616S, RPG618617S, RPG618618S, RPG6186
00643169720695
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.