RX Biliary M00545620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729337928), received between Mar 22, 2019 and Mar 31, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Break; Positioning Failure; Device Dislodged or Dislocated; Material Deformation; Break; Positioning Failure; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA RX BILIARY STENT WAS ATTEMPTED TO BE PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PLASTIC STENT PLACEMENT PROCEDURE IN THE DUODENUM AND COMMON BILE DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO PLACE THE STENT OVER A DREAMWIRE GUIDEWIRE, THE PULL WIRE CAME OUT FROM THE DELIVERY SYSTEM AND OUT OF THE SIDE OF THE FLEXIMA RX BILIARY STENT. ADDITIONALLY, IT WAS REPORTED THAT THE PUSH CATHETER AND PULL WIRE WAS KINKED AND THAT THE GUIDE CATHETER BROKE. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659157 ↗
• InjuryApr 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE GUIDE CATHETER WAS ADVANCED DOWN THE SCOPE FOR STENT DEPLOYMENT, THEY NOTICED WHEN IT REACHED TO THE AMPULLA, THE GUIDE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537056 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS BEING RELEASED, THE GUIDE CATHETER WAS BROKEN. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. HOWEVER, THE STENT WAS DEPLOYED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445653 ↗