BEUDAMED
    FDA Recall Terminated

    Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.

    Recall: Z-0885-2011 · Initiated December 18, 2009

    Recall

    Recall Number
    Z-0885-2011
    Event Number
    54685
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2009
    Posted
    January 7, 2011
    Terminated
    December 19, 2011
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.

    Reason

    Complaint about product quality: degradation of polymer portion of the distal section of the catheter.

    Action

    Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to [email protected].

    Distribution

    Worldwide. US Domestic including US Federal Government, and foreign countries.

    Quantity

    94,296 units