RX Biliary M00545660Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729301837), received between Jan 17, 2017 and Apr 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionApr 27, 2026Break; Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE STENT HAD AN UNSPECIFIED DAMAGE. THUS, ANOTHER FLEXIMA RX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICAITONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009178 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A PROCEDURE, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GUIDE CATHETER WAS SEPARATED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. ANOTHER FLEXIMA RX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13581300 ↗
• MalfunctionDec 31, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A PLASTIC STENT PLACEMENT IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, UPON THE DEPLOYING THE STENT INTO A COMMON BILE DUCT STRICTURE, THE METAL STYLET WAS RETRACTED COMPLETELY, HOWEVER, THE CLEAR PORTION OF THE INTRODUCER REMAINED WITHIN THE STENT, PREVENTING THE STENT FROM FULLY DEPLOYING. IT WAS NOTICED THAT THERE WAS A BREAK BETWEEN THE METAL STYLET AND THE GUIDE CATHETER. THE ENTIRE DELIVERY SYSTEM AND STENT WERE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13126264 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, AFTER THE STENT WAS POSITIONED IN THE TARGET SITE, THE GUIDE CATHETER BECAME SEPARATED AND FELL INTO THE DUODENUM. THE BROKEN GUIDE CATHETER WAS SUCCESSFULLY REMOVED USING A PAIR OF FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA 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 AS "NO PATIENT INJURY". A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941079 ↗
• MalfunctionJan 17, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, UPON OPENING OF THE PACKAGING, IT WAS OBSERVED THAT THE FLEXIMA RX BILIARY STENT WAS BENT AND KINKED. THE DEVICE WAS NOT USED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 6255791 ↗