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: 15427 units Lot/code info: GTIN 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK601201S, RTK602089S, RTK602953S, RTK603591S, RTK604031S, RTK600525S, RTK602527S, RTK606714S, RTK608837S, RTK608930S, RTK610777S, RTK600938S, RTK600939S, RTK600940S, RTK601391S, RTK601392S, RTK601393S, RTK601395S, RTK604983S, RTK604984S, RTK604033S, RTK606189S, RTK606293S, RTK606647S, RTK606683S, RTK606985S, RTK606988S, RTK607188S, RTK607189S, RTK607190S, RTK607191S, RTK607242S, RTK610835S, RTK603685S, RTK605333S, RTK601363S, RTK602275S, RTK602876S, RTK603055S, RTK600536S, RTK603273S, RTK603414S, RTK603912S, RTK604677S, RTK602444S, RTK602532S, RTK602533S, RTK602534S, RTK603360S, RTK603873S, RTK603874S, RTK603875S, RTK604155S, RTK604215S, RTK604626S, RTK607991S, RTK604065S, RTK604500S, RTK604161S, RTK610478S, RTK601877S, RTK606247S, RTK600611S, RTK609287S, RTK609288S, RTK609289S, RTK609290S, RTK609291S, RTK609293S, RTK609294S, RTK609295S, RTK609296S, RTK600247S, RTK600372S, RTK600622S, RTK601085S, RTK601214S, RTK602561S, RTK603534S, RTK603779S, RTK603793S, RTK603825S, RTK604693S, RTK604866S, RTK606038S, RTK609026S, RTK611004S, RTK617383S, RTK617202S, RTK605241S, RTK606999S, RTK609748S, RTK605348S, RTK605349S, RTK605351S, RTK605352S, RTK601439S, RTK601440S, RTK602471S, RTK602473S, RTK605980S, RTK605981S, RTK606707S, RTK606709S, RTK607336S, RTK617303S, RTK610172S, RTK601229S, RTK602257S, RTK602372S, RTK602380S, RTK603712S, RTK603886S, RTK604175S, RTK604227S, RTK6044
00763000178178
Official record: FDA (Device enforcement) ↗
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