Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, 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
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203, 805704, 806405, 806605, 807008, 807205, and 807905
Products Sold
729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203, 805704, 806405, 806605, 807008, 807205, and 807905
Boston Scientific Corporation is recalling Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Mate due to Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determ. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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, VT, VA, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026