RX Biliary M00545560Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729337867), received between Jan 30, 2017 and Sep 24, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Break

  It was reported to Boston Scientific Corporation that a Flexima RX Biliary Stent was to be implanted in the bile duct to treat stones during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During the procedure, the inner catheter got separated when this device was released. It could not be removed along with the delivery system in one piece. The broken guide catheter remained in the body, so it was removed using forceps and the procedure was completed with the original device.There were no patient complications reported as a results of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884569 ↗
• InjuryApr 18, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WERE TO BE USED IN THE BILE DUCT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WAS INSERTED ALONG THE GUIDEWIRE TO THE TARGET SITE AND RELEASED. THE ENDOSCOPE SCREEN WAS CHECKED AFTER RELEASE, AND IT WAS NOTICED THAT THE INNER CATHETER HAD BEEN SEPARATED AND REMAINED INSIDE THE STENT; THEREFORE, IT WAS REMOVED WITH FORCEPS. THE STENT WAS THEN REPOSITIONED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131053 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INNER GUIDE CATHETER BROKE OFF AFTER DEPLOYING THE STENT. THE BROKEN INNER GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE STENT REMAINED IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079757 ↗
• MalfunctionFeb 14, 2024Break; Material Deformation; Positioning Problem; Break; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SET WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PROXIMAL HANDLE WAS PULLED FOR RELEASE, THERE WAS NO RESISTANCE FELT; HOWEVER, IT WAS NO LONGER ABLE TO PULL THE INNER CATHETER IN THE MIDDLE OF THE PROCEDURE. SUBSEQUENTLY, WHEN THE ENDOSCOPE WAS REMOVED, IT WAS NOTICED THAT THE INNER CATHETER WAS BROKEN AND WAS REMOVED ALONG WITH THE PUSH CATHETER. THE STENT REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705989 ↗
• MalfunctionDec 14, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTED THAT THE GUIDE CATHETER WAS SEPARATED. ANOTHER FLEXIMA RX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982132 ↗
• MalfunctionDec 14, 2021Break; Premature Activation; Material Deformation; Break; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE WIRE SNAGGED AND THE STENT DEPLOYED PREMATURELY. THERE WERE NO INFORMATION ON HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005560 ↗
• MalfunctionApr 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED INTO THE PATIENT, WHEN THE STENT PLACEMENT EVALUATED, A PLASTIC FOREIGN OBJECT WAS SEEN ATTACHED TO THE STENT. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT AND NO NEW DEVICE WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953595 ↗
• InjuryMar 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE IN THE BILE DUCT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE CATHETER BECAME SEPARATED FROM THE DEPLOYMENT SYSTEM. THE BROKEN GUIDE CATHTER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON (B)(6)2020** THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT USING A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897642 ↗
• MalfunctionMar 9, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A BILE DUCT DRAINAGE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT, THE GUIDE CATHETER BECAME SEPARATED AT THE PROXIMAL PORTION. NO PART OF THE DEVICE FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806118 ↗
• MalfunctionFeb 20, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING BILE DUCT DRAINAGE IN THE BILE DUCT PERFORMED. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY TRIED TO RELEASE THE STENT, THE PROXIMAL PART OF THE GUIDE CATHETER OUTSIDE OF THE PATIENT HAD BROKEN. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE AND NO PART OF THE DEVICE FELL INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732605 ↗
• InjuryOct 7, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2019-04904 AND MFR. REPORT # 3005099803-2019-04905). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN BACKLOADED THE STENT ONTO THE GUIDEWIRE AND ADVANCED IT DOWN THE SCOPE AND INTO THE BILE DUCT OF THE PATIENT. UPON DEPLOYMENT OF THE STENT, THEY PULLED BACK THE PULL WIRE AND NOTICED THE STENT WAS DEPLOYED BUT THE CLEAR INTRODUCER PIECE OF THE GUIDE CATHETER WAS STILL IN THE MIDDLE OF THE STENT AND WAS NOT RETRIEVED INTO THE CATHETER SYSTEM LIKE IT SHOULD HAVE. THE PHYSICIAN MANAGED TO GET THE STENT AND BROKEN GUIDE CATHETER OUT WITH FORCEPS. THEY TRIED TO DEPLOY ANOTHER FLEXIMA RX BILIARY STENT BUT HAD THE SAME RESULT. THEY FINALLY TRIED A THIRD TIME WITH ANOTHER FLEXIMA RX BILIARY STENT AND COMPLETED THE PROCEDURE SUCCESSFULY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162106 ↗
• MalfunctionJul 3, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURIN A STENT PLACEMENT PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BUT THE WAS DIFFICULT TO ADVANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER DETACHED. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759689 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE PHYSICIAN FULLY DEPLOYED THE STENT, THE GUIDE CATHETER CAME APART INSIDE OF THE SCOPE. THE SCOPE WAS REMOVED OUT FROM THE PATIENT AND THE BROKEN PIECE OF CATHETER WAS REMOVED OUT FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228872 ↗
• InjuryJan 30, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FLEXIMA RX BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN COMMON BILE DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, UPON DEPLOYING THE STENT, AN AREA BROKE BETWEEN THE TWO CATHETERS AND THE DELIVERY SYSTEM. THE CLEAR GUIDE CATHETER STAYED INSIDE OF THE STENT, AND BOTH THE STENT AND BROKEN CATHETER HAD TO BE REMOVED WITH A SNARE. ANOTHER GUIDEWIRE WAS MANIPULATED WITHIN THE DUCT, AND THEN ANOTHER STENT WAS OPENED AND PLACED TO COMPLETE THE PROCEDURE. THIS PROCESS TOOK A TOTAL OF 20 ADDITIONAL MINUTES WHICH REQUIRED THE PATIENT TO BE UNDER ANESTHESIA LONGER. NO PATIENT ISSUES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287521 ↗