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: 2669 units Lot/code info: GTIN 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S, RTD602056S, RTD602058S, RTD602059S, RTD602060S, RTD602061S, RTD602062S, RTD602063S, RTD602064S, RTD602065S, RTD602066S, RTD602067S, RTD602272S, RTD602273S, RTD602274S, RTD602276S, RTD602278S, RTD602279S, RTD602280S, RTD602281S, RTD602282S, RTD602283S, RTD602284S, RTD602285S, RTD602287S, RTD602288S, RTD602289S, RTD602291S, RTD602292S, RTD602293S, RTD602294S, RTD602295S, RTD602296S, RTD602297S, RTD602298S, RTD603153S, RTD603945S, RTD603947S, RTD603949S, RTD603950S, RTD604012S, RTD604013S, RTD6040
00763000178109, 00763000178123, 00763000402228
Official record: FDA (Device enforcement) ↗
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