FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
- Recall number
- Z-2068-2010
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
- Status
- Terminated
- Initiated
- 2010-06-03
- Posted
- 2010-07-22
- Terminated
- 2011-12-10
- Reason
- 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
- Process design
- Action
- 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.
- Quantity
- 469 units
- Distribution
- 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.
- Lot, serial or model codes
- B17404, B18118, B18485, B18595, B18702, B18746
- 510(k) numbers
- ["K053268"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28