| Class 2 Device Recall FilterWire EZ" Embolic Protection System | |
Date Initiated by Firm | May 20, 2008 |
Date Posted | October 14, 2008 |
Recall Status1 |
Terminated 3 on December 10, 2011 |
Recall Number | Z-0107-2009 |
Recall Event ID |
49061 |
510(K)Number | K063313 |
Product Classification |
Catheter - Product Code NTE
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Product | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, OUS CV, Material H749201003990, Catalog # 20100-399, 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. |
Code Information |
731901, 803510, 803602, and 805603 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact | 800-272-3737 |
Manufacturer Reason for Recall | 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 ma |
FDA Determined Cause 2 | Employee error |
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. |
Quantity in Commerce | A total of 4338 units distributed. |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NTE
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