RX BiliaryRecalls & reported problems across all models
Boston Scientific Corporation · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 13 models of RX Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 24, 2026 — classified as 36 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Break” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RX Biliary problems
Device problems
- Break57
- Positioning Failure5
- Material Deformation4
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Positioning Problem2
- Premature Activation2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient33
- No Clinical Signs, Symptoms or Conditions24
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
- Discomfort1
RX Biliary models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RX Biliary M00545560CATHETER, BILIARY, DIAGNOSTIC14 reports
- RX Biliary M00545570CATHETER, BILIARY, DIAGNOSTIC13 reports
- RX Biliary M00545660CATHETER, BILIARY, DIAGNOSTIC5 reports
- RX Biliary M00545670CATHETER, BILIARY, DIAGNOSTIC5 reports
- RX Biliary M00545590CATHETER, BILIARY, DIAGNOSTIC5 reports
- RX Biliary M00545550CATHETER, BILIARY, DIAGNOSTIC4 reports
- RX Biliary M00545580CATHETER, BILIARY, DIAGNOSTIC4 reports
- RX Biliary M00545620CATHETER, BILIARY, DIAGNOSTIC3 reports
- RX Biliary M00545650CATHETER, BILIARY, DIAGNOSTIC2 reports
- RX Biliary M00545680CATHETER, BILIARY, DIAGNOSTIC2 reports
- RX Biliary M00545690CATHETER, BILIARY, DIAGNOSTIC2 reports
- RX Biliary M00545630CATHETER, BILIARY, DIAGNOSTIC1 report
- RX Biliary M00545600CATHETER, BILIARY, DIAGNOSTIC1 report
Recent RX Biliary adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 15, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS BROKEN/FRACTURED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511036 ↗MalfunctionJun 11, 2026Break; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH DUAL STENT PLACEMENT, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE ADVANCING THE DELIVERY SYSTEM THROUGH THE SCOPE, THE GUIDEWIRE DISLODGED FROM THE CATHETER, LEADING TO COMPLICATIONS. ADDITIONALLY, BOTH THE GUIDE CATHETER AND PUSH CATHETER BROKE. AS A RESULT, THE DELIVERY SYSTEM WAS REMOVED FROM THE SCOPE, AND ALL WIRES WERE WITHDRAWN TO ALLOW THE PROCEDURE TO BE RESTARTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480001 ↗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 ↗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 ↗MalfunctionMar 31, 2023Break; Positioning Failure; Device Dislodged or Dislocated; Material Deformation; Break; Positioning Failure; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA RX BILIARY STENT WAS ATTEMPTED TO BE PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PLASTIC STENT PLACEMENT PROCEDURE IN THE DUODENUM AND COMMON BILE DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO PLACE THE STENT OVER A DREAMWIRE GUIDEWIRE, THE PULL WIRE CAME OUT FROM THE DELIVERY SYSTEM AND OUT OF THE SIDE OF THE FLEXIMA RX BILIARY STENT. ADDITIONALLY, IT WAS REPORTED THAT THE PUSH CATHETER AND PULL WIRE WAS KINKED AND THAT THE GUIDE CATHETER BROKE. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED IN ONE PIECE. 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 16659157 ↗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 ↗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 ↗InjuryJul 24, 2022Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT, THE GUIDE CATHETER DETACHED FROM THE DEPLOYMENT MECHANISM AND HAD TO BE RETRIEVED. THE STENT WAS DEPLOYED IN PLACE SUCCESSFULLY AND 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 15090654 ↗InjuryJul 24, 2022Break; Premature Activation; Break; Premature Activation
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) 2022. DURING THE PROCEDURE, WHEN THE NURSE ATTEMPTED TO DEPLOY THE STENT AND PULLED BACK THE GUIDE CATHETER, THE STENT DEPLOYED PREMATURELY AND THE GUIDE CATHETER BROKE. THE PHYSICIAN RETRIEVED BOTH THE STENT AND GUIDE CATHETER AT THE SAME TIME USING A SNARE AND DECIDED NOT TO PLACE ANOTHER STENT TO ADEQUATE THE BILE DRAINAGE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT 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 15090638 ↗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 ↗MalfunctionFeb 8, 2022Break; Material Deformation; Break; Material Deformation
NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDE CATHETER WAS BROKEN. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PUSH CATHETER WAS KINKED. 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 13479107 ↗InjuryFeb 8, 2022Break; Positioning Failure; Break; Positioning Failure
NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN. THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT. THE PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PUSH CATHETER WAS KINKED AND THE GUIDE CATHETER WAS DETACHED. 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 13478900 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page