BEUDAMED
    FDA Recall 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 · Initiated February 23, 2015

    Recall

    Recall Number
    Z-1276-2015
    Event Number
    70644
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2015
    Posted
    March 17, 2015
    Terminated
    October 7, 2015
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391

    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.

    Action

    The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: [email protected] or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization. Your Medtronic field representative may assist the customers with identifying suitable replacement product. If you have any questions, contact Customer Service at 1-800-848-9300.

    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)