BEUDAMED
    FDA Enforcement Class II Terminated

    Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

    Recall: Z-1687-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1687-2019
    Event ID
    82746
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2019
    Initiation Date
    May 1, 2019
    Classification Date
    May 29, 2019
    Termination Date
    December 11, 2020
    Address
    26531 Ynez Rd, N/A, Temecula, CA, 92591-4630, United States

    Description

    Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

    Reason

    Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.

    Code Info

    All Serial Numbers.

    Distribution

    U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MACAU, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED KINGDOM

    Quantity

    N/A