Recalls / —
—#92562
Product
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm, REF 50-814, UPN M001508140 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K053268
- Affected lot / code info
- B18947
Why it was recalled
Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a P
Root cause (FDA determination)
Process design
Action the firm took
Consignees were sent on 6/3/10 an "Urgent Medical Device Recall" letter dated 3 June 2010. The letter was addressed to Risk Manger/Interventional Radiology Manger/Material Manger. The letter described the problem and the product involved. The letter included the "Customer Instructions" which stated to Immediately discontinue use of an segregate recalled product and, requested customers to return the Reply Verification Tracking Form. Questions are directed to the firm at 510-624-2563.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Scimed Pl, Maple Grove, Minnesota 55311-1565
Distribution
- Distribution pattern
- AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MD, MA, MS, NV, NY, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT,VA, WA, WT.
Timeline
- Recall initiated
- 2010-06-03
- Posted by FDA
- 2010-07-22
- Terminated
- 2011-12-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #92562. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.