BEUDAMED
    FDA Enforcement Class I Terminated

    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

    Recall: Z-1276-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1276-2015
    Event ID
    70644
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 25, 2015
    Initiation Date
    February 23, 2015
    Classification Date
    March 17, 2015
    Termination Date
    October 7, 2015
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391, United States

    Description

    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

    Reason

    Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

    Code Info

    Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.

    Distribution

    Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.

    Quantity

    151 (4 US, 147 OUS)