BEUDAMED
    FDA Recall Terminated

    Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.

    Recall: Z-1655-2012 · Initiated January 17, 2012

    Recall

    Recall Number
    Z-1655-2012
    Event Number
    61825
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 17, 2012
    Posted
    May 24, 2012
    Terminated
    July 19, 2012
    Address
    6464 Sycamore Ct N, Minneapolis, MN, 55369-6032

    Description

    Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.

    Reason

    Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.

    Action

    Vascular Solutions sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product , immediately remove the product and place the product in a secure area. Additionally, customers were asked to complete and return a Field Action Customer Inventory Form to the Customer Service Department via fax at 763-656-4251 or e-mail at [email protected]. Customers may contact their local sales representative for questions concerning this recall.

    Distribution

    Nationwide Distribution including the states of AL, AZ, AR, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LAM ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, WV, and WI.

    Quantity

    330