RX Biliary M00545590Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729337898), received between Mar 1, 2017 and Mar 6, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS TO BE USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE STENT INTRODUCER BROKE UPON STENT DEPLOYMENT. THE BROKEN INTRODUCER WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A PAIR OF RAT TOOTH FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491042 ↗
• InjuryJan 12, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHEN THE 7FR X 15CM RX BILIARY PLASTIC STENT WAS SUCCESSFULLY PLACED, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE AND WAS LEFT HANGING OUT FROM THE STENT. HOWEVER, THE PHYSICIAN MANAGED TO PULL THE GUIDE CATHETER OUT USING A RAT TOOTH AND THE STENT WAS SUCCESSFULLY IMPLANTED. REPORTEDLY, THE STENT WILL STAY IN THE PATIENT FOR 60 TO 150 DAYS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE GOOD AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11156423 ↗
• InjuryFeb 26, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING THE PROCEDURE. THE EXACT DATE OF THE EVENT WAS NOT REPORTED NOR THE PROCEDURE NAME. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ATTEMPTED TO RELEASE THE STENT, THE GUIDE CATHETER BROKE INSIDE THE PATIENT AND THE STENT DEPLOYED PREMATURELY. THE BROKEN DEVICE WAS REMOVED ALONG WITH THE STENT USING A SNARE OR FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372017 ↗
• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT AS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE IN THE SPHINCTER OF ODDI PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHEN ATTEMPTED TO PLACE THE FLEXIMA RX BILIARY STENT, THE GUIDE CATHETER COMPLETELY BROKE OFF INSIDE THE PATIENT AND SEPARATED FROM THE DELIVERY SYSTEM. THE BROKEN PIECE OF GUIDE CATHETER WAS REMOVED WITH BIOPSY FORCEPS. HOWEVER THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 "STABLE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175527 ↗
• InjuryMar 1, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, AFTER THE FLEXIMA RX BILIARY STENT DEPLOYMENT, IT WAS NOTICED THAT A PIECE OF CLEAR PLASTIC REMAINED IN THE STENT WHICH WAS MOST LIKELY THE GUIDE CATHETER OF THE DELIVERY SYSTEM. IN ADDITION, A PIECE OF GUIDE CATHETER DID NOT CAUSE ANY HARM TO THE PATIENT. FURTHERMORE, A BIOPSY FORCEPS WAS USED TO REMOVE THE PLASTIC PIECE OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 6368768 ↗