RX Biliary M00545570Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729337874), received between Nov 15, 2016 and May 21, 2020 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA RX BILIARY STENT WAS USED DURING STENT PLACEMENT IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON PLACING THE STENT, THE GUIDE CATHETER BECAME SEPARATED. A SNARE WAS USED TO REMOVE THE DETACHED PORTION OF THE GUIDE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079398 ↗
• InjuryMar 13, 2020Break; Break

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, THE GUIDE CATHETER BECAME DETACHED. THE BROKEN PIECE OF THE GUIDE CATHETER WAS REMOVED WITH A PAIR OF FORCEPS FROM THE PATIENT. REPORTEDLY, THE FLEXIMA RX BILIARY STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831205 ↗
• InjuryMar 13, 2020Break; Break

  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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, THE GUIDE CATHETER BECAME DETACHED. THE BROKEN PIECE OF THE GUIDE CATHETER WAS REMOVED WITH A PAIR OF FORCEPS FROM THE PATIENT. REPORTEDLY, THE FLEXIMA RX BILIARY STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831130 ↗
• InjuryDec 2, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A STENT REPLACEMENT IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. IT WAS NOTED THAT A LOCAL ANESTHESIA WAS USED IN THE PROCEDURE BUT IT DID NOT WORK WELL AND THE PATIENT WOULD NOT CALM DOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS RELEASED, A SEVERE RESISTANCE WAS ENCOUNTERED AND THE GUIDE CATHETER BROKE. A SNARE WAS USED TO RETRIEVE THE BROKEN GUIDE CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS 'NO PROBLEM'.

  Patient problems: Discomfort

  MAUDE report 9397953 ↗
• 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 OF THE PATIENT WITH FORCEPS. THE PHYSICIAN THEN TRIED TO DEPLOY ANOTHER STENT BUT HAD THE SAME RESULT AS THE FIRST STENT. THEY FINALLY TRIED A THIRD TIME WITH ANOTHER 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 9162125 ↗
• MalfunctionSep 19, 2019Device Fell

  THE PATIENT WAS UNDERGOING AN ERCP IN THE ENDOSCOPY SUITE. THE DEVICE WAS INTRODUCED AND ACCORDING TO STAFF, "THE STENT WAS DEPLOYED AND (THE) TRANSDUCER ON (THE) STENT FELL OFF INTO (THE) PATIENT." THE TRANSDUCER WAS QUICKLY RETRIEVED WITH NO HARM COMING TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9086176 ↗
• InjurySep 17, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, THE GUIDE CATHETER WAS DISLODGED FROM THE PUSH CATHETER. A SNARE WAS USED TO REMOVE THE BROKEN GUIDE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. "THE PATIENT WAS UNDERGOING AN ERCP IN THE ENDOSCOPY SUITE. THE DEVICE WAS INTRODUCED AND ACCORDING TO STAFF,"THE STENT WAS DEPLOYED AND (THE ) TRANSDUCER ON (THE) STENT FELL OFF INTO (THE) PATIENT". THE TRANSDUCER WAS QUICKLY RETRIEVED WITH NO HARM COMING TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078829 ↗
• InjuryMay 7, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN. THE BROKEN PIECE OF THE GUIDE CATHETER WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS STOPPED DUE TO THIS EVENT AND HAS BEEN RESCHEDULED TO ANOTHER DATE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS 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 8587224 ↗
• InjurySep 19, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE INSIDE THE PATIENT. THE BROKEN PIECE OF GUIDE CATHETER WAS RETRIEVED USING A PAIR OF RAT TOOTH FORCEPS AND THE PROCEDURE WAS SUCCESSFULLY 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 7889502 ↗
• InjuryNov 14, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED TO A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, IT WAS NOTICED THAT GUIDE CATHETER BROKE AND STAYED INSIDE THE PATIENT. THE BROKEN PIECE OF GUIDE CATHETER HAD TO BE REMOVED WITH A SNARE. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. 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 7027862 ↗
• InjuryOct 11, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING BILIARY DRAINAGE PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHILE RELEASING THE STENT, SEVERE RESISTANCE WAS FELT ON THE HAND BASE. WHEN THE PHYSICIAN TRIED TO CONTINUE THE DEPLOYMENT, THE GUIDE CATHETER BROKE AND STAYED INSIDE THE PATIENT. THE STENT WAS PULLED OUT FROM ENDOSCOPE AND THE BROKEN PIECE OF CATHETER HAD TO BE REMOVED BY FORCEPS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE FLEXIMA RX BILIARY STENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939670 ↗
• InjuryMay 10, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SET WAS USED DURING AN ENDOSCOPIC STENT PLACEMENT PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED, IT WAS OBSERVED UNDER ENDOSCOPIC IMAGE THAT THE INNER GUIDE CATHETER HAD DETACHED AND WAS SEEN COMING OUT FROM THE LUMEN PART OF THE STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN GUIDE CATHETER PIECE FROM THE STENT, HOWEVER, WHEN THE OBJECT WAS PULLED IT WAS NOTICED THAT THE STENT ITSELF WAS PULLED OUT AS WELL. THEREFORE, THE ENTIRE BROKEN CATHETER PIECE AND THE STENT WAS RETRIEVED AND TOTALLY REMOVED FROM THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 6556863 ↗
• InjuryNov 15, 2016Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA" RX BILIARY STENT SET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS DEPLOYING THE STENT AND PART OF THE GUIDE CATHETER BROKE OFF WHILE IT WAS HALF WAY INSIDE THE STENT. THE PHYSICIAN USED A SNARE AND RETRIEVED THE BROKEN GUIDE CATHETER, THEN WENT DOWN WITH RAT TOOTH FORCEPS TO PUSH THE STENT INTO PLACE. 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 6101376 ↗