BEUDAMED
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    Filters FDA Adverse Event ×

    2030404-2011-00274

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·October 12, 2011

    2030404-2018-00067

    FDA Adverse Event
    Injury ·September 18, 2018

    2030404-2010-00083

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·July 29, 2010

    INTRODUCER, ELECTROPHYSIOLOGY

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·July 25, 2016

    TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 98CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 19, 2011

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL (AFD-PLYMOUTH)·Product code DYB·July 25, 2016

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code DYB·December 20, 2013

    AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·October 23, 2014

    BRK? TRANSSEPTAL NEEDLE, 98 CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DRC·October 23, 2014

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAD·September 20, 2019

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DRF·September 20, 2019

    BRK TRANSSEPTAL NEEDLE, BRK-1 XS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·April 24, 2012

    INTRODUCER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 8, 2012

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 8, 2012

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·April 6, 2012

    SUPREME EP CATHETER, 6F, QUADRIPOLAR, 5MM, CRD-2

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·April 6, 2012

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL·Product code DYB·June 11, 2019

    BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code DRC·June 11, 2019

    FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAD·August 31, 2015

    INQUIRY STEERABLE CATHETER, 1104-6-25-L

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code DRF·December 31, 2013