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: 4151 units Lot/code info: GTIN 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH602306S, RTH605169S, RTH602089S, RTH603993S, RTH601526S, RTH600467S, RTH600514S, RTH600533S, RTH600607S, RTH600608S, RTH601387S, RTH601543S, RTH601544S, RTH601545S, RTH602017S, RTH605116S, RTH600520S, RTH602108S, RTH604790S, RTH602149S, RTH605081S, RTH605082S, RTH604360S, RTH604780S, RTH604943S, RTH604734S, RTH600153S, RTH601390S, RTH601395S, RTH601849S, RTH601868S, RTH602192S, RTH602619S, RTH600554S, RTH602035S, RTH602694S, RTH600170S, RTH602206S, RTH601611S, RTH602091S, RTH602195S, RTH603628S, RTH600220S, RTH600223S, RTH600228S, RTH600288S, RTH601447S, RTH601448S, RTH601449S, RTH601450S, RTH602055S, RTH602056S, RTH602057S, RTH602058S, RTH602059S, RTH602060S, RTH602061S, RTH602064S, RTH602065S, RTH602067S, RTH602069S, RTH602071S, RTH602072S, RTH602073S, RTH602074S, RTH602077S, RTH602078S, RTH602079S, RTH602271S, RTH602272S, RTH602276S, RTH602277S, RTH602288S, RTH602625S, RTH602626S, RTH602627S, RTH602628S, RTH602629S, RTH602630S, RTH602631S, RTH602632S, RTH602633S, RTH602634S, RTH602635S, RTH602639S, RTH602640S, RTH602641S, RTH602642S, RTH602643S, RTH602645S, RTH602646S, RTH603959S, RTH603977S, RTH603986S, RTH604454S, RTH604455S, RTH604456S, RTH600592S, RTH601482S, RTH601553S, RTH601555S, RTH601556S, RTH601558S, RTH601563S, RTH601564S, RTH601567S, RTH602618S, RTH601756S, RTH601641S, RTH600460S, RTH601716S, RTH601948S, RTH602517S, RTH600294S, RTH600472S, RTH6004
00763000178147, 00763000178161
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.