BEUDAMED
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    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·June 19, 2013

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·June 19, 2013

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 18, 2026

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·May 24, 2024

    CARDIAC CONTROL SYSTEMS INC.

    FDA Adverse Event
    Malfunction ·CCS·Product code DXY·August 7, 2001

    IFS ADVANCED FEMTOSEC LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code GEX·March 28, 2024

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·April 11, 2024

    DAVINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 12, 2024

    DAVINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 19, 2022

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 6, 2026

    PURGE CASSETTE GEN 2, STERILE, NON QSK

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·February 24, 2026

    ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HOOK & HALO WITHOUT DILATOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·May 2, 2018

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·January 22, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·April 25, 2024

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 12, 2026

    BERLIN HEART EXCOR PEDIATRIC VAD

    FDA Adverse Event
    Death ·BERLIN HEART GMBH·Product code DSQ·June 3, 2019

    RP FLEX W SMART ASSIST SET, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code PYX·March 5, 2026

    RP FLEX W SMART ASSIST SET, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code PYX·March 5, 2026

    RP FLEX W SMART ASSIST SET, US

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code PYX·March 16, 2026

    DAVINCI SI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 22, 2023