Z-0109-2009

Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV...

Name: Z-0109-2009 Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV...
Creator: Boston Scientific Corporation
Published: 2008-05-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-05-20 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2008-05-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0109-2009
Status: Terminated
Initiated: 2008-05-20
Posted: 2008-10-14
Terminated: 2011-12-10
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: NTE Temporary Carotid Catheter For Embolic Capture
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 may
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 728107, 728212, 730406, 730505, 731101, 731201, 731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507, 806602, 807902, 808004, 808501, and 808602

Product code NTE

K063313Class IIFilterwire Ez Embolic Protection System (3.5 Mm to 5.5 Mm)Boston Scientific Corp / cleared 2006-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)