BEUDAMED
    FDA Recall Terminated

    Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog # 20105-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA 94043-4655. Filter wire EZ" Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

    Recall: Z-0109-2009 · Initiated May 20, 2008

    Recall

    Recall Number
    Z-0109-2009
    Event Number
    49061
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    NTE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 20, 2008
    Posted
    October 14, 2008
    Terminated
    December 10, 2011
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog # 20105-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA 94043-4655. Filter wire EZ" Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

    Reason

    Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing. If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU. This may

    Action

    Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 20, 2008. The letter addressed to Risk Mangers, described the issue and product. A Reply Verification Tracking Form was requested to be completed and returned. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.

    Distribution

    US: AL AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD. TN, TX. UT, VA, VT, WV, WA, WI, WY, and PR. European Countries: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Great Britain, Germany, Greece, Hungary, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, and Switzerland, Intercontinental: Taiwan, Korea, Australia, China, Singapore, Canada, Columbia, and Mexico.

    Quantity

    A total of 4338 units distributed.