Recall Z-0106-2009
Boston Scientific Corporation · initiated May 20, 2008
Product
Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, US, Material H749201003000, Catalog # 20100-300, 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.
Codes / lots: 728206, 731007, 731704, 731809, and 807108
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
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0106-2009
- Initiated
- May 20, 2008
- Posted by FDA
- October 14, 2008
- Terminated
- December 10, 2011
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Quantity
- 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…
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0105-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | 05/20/2008Terminated |
| Z-0107-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | 05/20/2008Terminated |
| Z-0108-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | 05/20/2008Terminated |
| Z-0109-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | 05/20/2008Terminated |
| Z-0110-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5…Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic… | 05/20/2008Terminated |