Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H74920105
FDA device recall Z-0110-2009 · posted 2008-10-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NTE
- Quantity affected
- 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, W
- Date initiated
- 2008-05-20
- Date posted
- 2008-10-14
- Date terminated
- 2011-12-10
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) (K063313) | Boston Scientific Corp | 2006-12-05 |