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: 425 units Lot/code info: GTIN 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN203258H, BWN203259H, BWN203304H, BWN203477H, BWN203665H, BWN203423H, BWN203403H, BWN203327H, BWN203518H, BWN203790H, BWN203174H, BWN203624H, BWN203750H, BWN203763H, BWN203786H, BWN203745H, BWN203526H, BWN203813H, BWN203168H, BWN203236H, BWN203374H, BWN203463H, BWN203640H, BWN203213H, BWN203431H, BWN203492H, BWN203585H, BWN203436H, BWN203524H, BWN203528H, BWN203809H, BWN203432H, BWN203231H, BWN203199H, BWN203163H, BWN203193H, BWN203306H, BWN203310H, BWN203352H, BWN203373H, BWN203433H, BWN203575H, BWN203611H, BWN203616H, BWN203689H, BWN203732H, BWN203739H, BWN203749H, BWN203796H, BWN203799H, BWN203803H, BWN203181H, BWN203642H, BWN203202H, BWN203758H, BWN203671H, BWN203769H, BWN203357H, BWN203248H, BWN203253H, BWN203448H, BWN203664H, BWN203733H, BWN203260H, BWN203347H, BWN203408H, BWN203422H, BWN203535H, BWN203582H, BWN203712H, BWN203770H, BWN203697H, BWN203205H, BWN203410H, BWN203590H, BWN203332H, BWN203381H, BWN203430H, BWN203511H, BWN203737H, BWN203355H, BWN203703H, BWN203625H, BWN203380H, BWN203498H, BWN203620H, BWN203622H, BWN203810H, BWN203681H, BWN203685H, BWN203434H, BWN203653H, BWN203564H, BWN203169H, BWN203188H, BWN203186H, BWN203318H, BWN203325H, BWN203544H, BWN203468H, BWN203727H, BWN203283H, BWN203693H, BWN203667H, BWN203180H, BWN203660H, BWN203584H, BWN203386H, BWN203806H, BWN203543H, BWN203417H, BWN203395H, BWN203549H, BWN203279H, BWN203326H, BWN2037
00643169720619
Official record: FDA (Device enforcement) ↗
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