RX Biliary M00545550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729337850), received between Apr 3, 2020 and Oct 22, 2021 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS OPENED TO BE USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EVENT DATE WAS NOT REPORTED. DURING PREPARATION, IT WAS NOTED THAT THERE WAS A HOLE IN THE PACKAGING. IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THEY OPENED ANOTHER FLEXIMA RX BILIARY STENT 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 12686045 ↗
• InjurySep 14, 2020Break; 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 RX BILIARY STENT WAS USED DURING A BILIARY DRAINAGE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE CATHETER BECAME SEPARATED DURING ATTEMPTED STENT DEPLOYMENT. THE BROKEN GUIDE CATHETER REMAINED INSIDE THE STENT WHICH WAS PLACED IN THE BILE DUCT. THE PHYSICIAN THOUGHT THE STENT WAS PUSHED BY A STRICTURE AND THERE WAS A SEVERE RESISTANCE WHEN THE INNER CATHETER WAS REMOVED. A PAIR OF FORCEPS WAS USED TO REMOVE THE BROKEN GUIDE CATHETER AND THE STENT FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED ON THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10528797 ↗
• InjuryMay 21, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, THE GUIDE CATHETER BECAME SEPARATED AND REMAINED INSIDE THE STENT. THE PHYSICIAN USED GRASPING FORCEPS TO REMOVE THE BROKEN GUIDE CATHETER FROM 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 10080735 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A BILIARY STENT PLACEMENT IN THE LOWER BILE DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS RELEASED, THEY HAVE OBSERVED THAT THE STENT WAS UNABLE TO SEPARATE FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922648 ↗