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: 1941 units Lot/code info: GTIN 00763000178376, Lot Serial Numbers: RSN600341S, RSN601060S, RSN601316S, RSN601817S, RSN602193S, RSN600668S, RSN600669S, RSN600670S, RSN600672S, RSN601804S, RSN601808S, RSN601810S, RSN602514S, RSN601050S, RSN601241S, RSN602551S, RSN600820S, RSN603061S, RSN601870S, RSN602495S, RSN601384S, RSN601691S, RSN601237S, RSN602951S, RSN603065S, RSN600626S, RSN600877S, RSN601019S, RSN601020S, RSN601022S, RSN601027S, RSN601028S, RSN601029S, RSN601030S, RSN601032S, RSN601038S, RSN601040S, RSN600997S, RSN601013S, RSN601039S, RSN600837S, RSN601913S, RSN601957S, RSN600334S, RSN600116S, RSN602781S, RSN602004S, RSN602073S, RSN601983S, RSN600628S, RSN601374S, RSN600624S, RSN601004S, RSN601902S, RSN602210S, RSN600402S, RSN600359S, RSN600360S, RSN600361S, RSN600366S, RSN601283S, RSN602071S, RSN602182S, RSN602365S, RSN602756S, RSN602171S, RSN600482S, RSN600870S, RSN601950S, RSN602490S, RSN600952S, RSN602026S, RSN602072S, RSN602244S, RSN602297S, RSN600640S, RSN601351S, RSN601352S, RSN601830S, RSN601831S, RSN600813S, RSN600891S, RSN601202S, RSN601390S, RSN602166S, RSN602167S, RSN602245S, RSN600550S, RSN601897S, RSN602283S, RSN602325S, RSN602485S, RSN600459S, RSN600461S, RSN600463S, RSN600574S, RSN600639S, RSN600918S, RSN601080S, RSN601116S, RSN601140S, RSN601152S, RSN601207S, RSN601302S, RSN601694S, RSN602029S, RSN602194S, RSN600673S, RSN601354S, RSN602346S, RSN601149S, RSN601829S, RSN601832S, RSN601874S, RSN600522S, RSN602059S, RSN602379S, RSN602424S, RSN601230S, RSN601402S, RSN602202S, RSN6023
00763000178376, 00763000178383
Official record: FDA (Device enforcement) ↗
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