BEUDAMED
    FDA Enforcement Class II Terminated

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    Recall: Z-1566-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1566-2013
    Event ID
    65343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Loma Vista Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    March 18, 2013
    Classification Date
    June 21, 2013
    Termination Date
    July 17, 2013
    Address
    863 Mitten Rd Ste 100A, Burlingame, CA, 94010-1307, United States

    Description

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    Reason

    Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.

    Code Info

    All lot numbers lower than PLN00749 are subject to this recall.

    Distribution

    Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.

    Quantity

    2379 units