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    Medtronic CryoCath LP

    FDA registration
    Medtronic CryoCath LP·5 products·🇨🇦 Canada

    NA

    FDA UDI
    Medtronic CryoCath LP·00643169449596·CONSOLE 106A3 GEN V CRYOCONSOLE

    NA

    FDA UDI
    Medtronic CryoCath LP·00643169352476·CONSOLE 106A3 GENV US ROHS

    NA

    FDA UDI
    Medtronic CryoCath LP·00643169195844·CONSOLE 106A3 GEN V CRYO US LOANER

    NA

    FDA UDI
    Medtronic CryoCath LP·00763000486778·CONSOLE 106A3 GEN V ROHS PLX

    Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code OAE·August 29, 2011

    Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP, Kirkland, Quebec H9H 5H3, Canada. Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DRA·July 15, 2011

    VALLEYLAB FT10

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·December 5, 2022

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·October 19, 2016

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·December 29, 2016

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·November 29, 2016

    CRYOCONSOLE

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code LPB·November 2, 2016

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·November 14, 2016

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·December 13, 2016

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Death ·MEDTRONIC CRYOCATH LP·Product code DRA·December 27, 2016

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·November 28, 2016

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·December 8, 2016

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·October 19, 2016

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·November 16, 2016

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·October 11, 2016