BEUDAMED
    FDA Recall 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 · Initiated March 18, 2013

    Recall

    Recall Number
    Z-1566-2013
    Event Number
    65343
    Firm
    Loma Vista Medical
    FEI Number
    3009391754
    Product Code
    OZT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 18, 2013
    Posted
    June 21, 2013
    Terminated
    July 17, 2013
    Address
    863 Mitten Rd, Ste 100A, Burlingame, CA, 94010-1307

    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.

    Action

    The firm sent an "URGENT VOLUNTARY DEVICE REMOVAL" letter dated March 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    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