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: 2831 units Lot/code info: GTIN 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S, CWS600765S, CWS600805S, CWS600806S, CWS600807S, CWS601024S, CWS601111S, CWS601201S, CWS601718S, CWS601979S, CWS602753S, CWS600731S, CWS601304S, CWS601780S, CWS602108S, CWS602214S, CWS601240S, CWS602411S, CWS602889S, CWS600108S, CWS601150S, CWS602620S, CWS601627S, CWS600523S, CWS600244S, CWS600631S, CWS600234S, CWS600315S, CWS600412S, CWS600432S, CWS600699S, CWS600804S, CWS601098S, CWS601210S, CWS601219S, CWS601223S, CWS601225S, CWS601309S, CWS601313S, CWS601431S, CWS601434S, CWS601723S, CWS6019
00763000001568
Official record: FDA (Device enforcement) ↗
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