BEUDAMED
    FDA Recall Terminated

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    Recall: Z-2450-2012 · Initiated August 20, 2012

    Recall

    Recall Number
    Z-2450-2012
    Event Number
    63092
    Firm
    Abbott Vascular
    FEI Number
    2024168
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 20, 2012
    Posted
    September 25, 2012
    Terminated
    July 15, 2013
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    Reason

    Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.

    Action

    An "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.

    Distribution

    Nationwide(US) Distribution and Puerto Rico.

    Quantity

    61,799 units