Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lot Numbers: 12012906, 12013569 and 12039341.
Products Sold
Lot Numbers: 12012906, 12013569 and 12039341.
Boston Scientific Corp is recalling Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 due to The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval ba. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated January 8, 2009 to discontinue use of the affected product and to return it to Boston Scientific. Customers were instructed to complete and fax the Reply Verification Tracking Form to Boston Scientific at 508-683-5578. Direct questions about this recall to your local Sales Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026