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: 2310 units Lot/code info: GTIN 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE601482S, CWE601602S, CWE602520S, CWE602570S, CWE602622S, CWE601590S, CWE602288S, CWE601918S, CWE602150S, CWE602184S, CWE602565S, CWE602589S, CWE600926S, CWE600588S, CWE601390S, CWE601395S, CWE601481S, CWE601541S, CWE601612S, CWE601749S, CWE601831S, CWE601843S, CWE602038S, CWE600874S, CWE601632S, CWE601996S, CWE602041S, CWE601792S, CWE602396S, CWE600375S, CWE601990S, CWE600553S, CWE601369S, CWE601392S, CWE601766S, CWE601769S, CWE601695S, CWE601401S, CWE601470S, CWE602016S, CWE602094S, CWE602195S, CWE602495S, CWE600746S, CWE601256S, CWE600733S, CWE601348S, CWE601487S, CWE601524S, CWE600350S, CWE600974S, CWE601438S, CWE601700S, CWE601989S, CWE602012S, CWE602376S, CWE600461S, CWE600373S, CWE600530S, CWE601325S, CWE601582S, CWE601644S, CWE601701S, CWE601995S, CWE601282S, CWE601850S, CWE601890S, CWE600526S, CWE602605S, CWE600525S, CWE600372S, CWE600396S, CWE601006S, CWE601277S, CWE601694S, CWE601596S, CWE601652S, CWE601992S, CWE602044S, CWE601462S, CWE601538S, CWE600725S, CWE600729S, CWE601579S, CWE602053S, CWE601643S, CWE602123S, CWE601993S, CWE600935S, CWE600936S, CWE601442S, CWE601444S, CWE601533S, CWE602080S, CWE602135S, CWE600502S, CWE600735S, CWE600864S, CWE601922S, CWE601927S, CWE602035S, CWE602078S, CWE602118S, CWE602122S, CWE602156S, CWE602169S, CWE602232S, CWE602241S, CWE602380S, CWE602423S, CWE602426S, CWE602508S, CWE602539S, CWE602554S, CWE602379S, CWE6008
00643169837768, 00763000206178, 00763000612030
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.