BEUDAMED
    FDA Recall Terminated

    Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)

    Recall: Z-2858-2011 · Initiated June 3, 2011

    Recall

    Recall Number
    Z-2858-2011
    Event Number
    59051
    Firm
    Terumo Medical Corporation
    FEI Number
    1118880
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2011
    Posted
    July 20, 2011
    Terminated
    July 27, 2011
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322

    Description

    Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)

    Reason

    Baloon catheter guidewires may become uncoiled during angioplasty procedures.

    Action

    Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.

    Distribution

    Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.

    Quantity

    70 units