FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
- Recall number
- Z-0978-2009
- Recalling firm
- Boston Scientific Corporation
- Product
- Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
- Status
- Terminated
- Initiated
- 2008-12-24
- Posted
- 2009-02-13
- Terminated
- 2010-05-11
- Reason
- Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
- Root cause
- Packaging process control
- Action
- A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.
- Quantity
- 15,334
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Lot Numbers for UPN M00560100: 9261338, 9283882, 9305162, 9327239, 9369045, 9372244, 9412852, 9451457, 9505237, 9521511, 9592459, 9633852, 9681234, 9722306, 9753577, 9754934, 9754935, 9754936, 9810372, 9824002, 11015389, 11036295, 11057651, 11083694, 11147192, 11204692, 11229075, 11263907, 11320518, 11357567, 11390523, 11394227, 11463699, 11525430, 11544096, 11595300, 11617465, 11661744, 11696754, 11742585, 11767910, 11815749, 11871189, 11899606, 11975822, 12027023 and 12051845. Lot Numbers for UPN M00560101: 9256060, 9356184, 9473937, 9562330, 9644511, 9774420, 11043881, 11132563, 11194002, 11284265, 11324380, 11460248, 11573667, 11624658, 11716593, 11830799, 11979368 and 12030396.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 1051710
- Firm city
- Miami
- Firm state
- FL
- 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