Events

Recall of Device Recall FilterWire EZ" Embolic Protection System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49061
  • Event Risk Class
    Class 2
  • Event Number
    Z-0109-2009
  • Event Initiated Date
    2008-05-20
  • Event Date Posted
    2008-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72660
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter - Product Code NTE
  • 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.

Device

Device Recall FilterWire EZ" Embolic Protection System
  • Model / Serial
    728107, 728212, 730406, 730505, 731101, 731201, 731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507, 806602, 807902, 808004, 808501, and 808602
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA