Boston Scientific, Fathom"-14 Steerable Guidewire… recallZ-2071-2010 · Boston Scientific Corporation · initiated Jun 3, 2010
Terminated All recalls posted in July 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2071-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 3, 2010
- Posted by the FDA
- Jul 22, 2010
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 78 units
- Product code
- DQX
- FDA submissions
- K053268
- 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.
Product description
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
Code information (models, lots, serial numbers)
B17847, B18948
Other devices under the same FDA submission
8 devices cleared under K053268 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- SYNCHRO 2 M00326010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls79 reports
- SYNCHRO 2 M00326510Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls41 reports
- SYNCHRO 2 M00326420Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls18 reports
- SYNCHRO 2 M00326110Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls14 reports
- SYNCHRO 2 M00326310Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls5 reports
- SYNCHRO 2 M00326520Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls1 report
- SYNCHRO 2 M00326320Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 56059).
- Z-2068-2010 · TerminatedBoston 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 Ori…
- Z-2069-2010 · TerminatedBoston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made …
- Z-2070-2010 · TerminatedBoston 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 Ori…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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