Flexima BiliaryRecalls & reported problems across all models
Boston Scientific Corporation · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 241
- Deaths reported
- 1
- Injuries reported
- 19
- Recalls
- 0
We found 15 models of Flexima Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2017 and Sep 29, 2026 — classified as 1 death, 19 injuries, 221 malfunctions.
The most frequently reported specific device problem is “Break” (197 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 Flexima Biliary problems
Device problems
- Break197
- Positioning Failure110
- Adverse Event Without Identified Device or Use Problem57
- Use of Device Problem35
- Material Deformation32
- Material Split, Cut or Torn16
- Stretched16
- Activation, Positioning or Separation Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions174
- No Consequences Or Impact To Patient63
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Flexima Biliary models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flexima™ Biliary M00539220CATHETER, BILIARY, DIAGNOSTIC41 reports
- Flexima™ Biliary M00539260CATHETER, BILIARY, DIAGNOSTIC41 reports
- Flexima™ Biliary M00539270CATHETER, BILIARY, DIAGNOSTIC34 reports
- Flexima™ Biliary M00539210CATHETER, BILIARY, DIAGNOSTIC26 reports
- Flexima™ Biliary M00539280CATHETER, BILIARY, DIAGNOSTIC21 reports
- Flexima™ Biliary M00539230CATHETER, BILIARY, DIAGNOSTIC1 death15 reports
- Flexima™ Biliary M00539200CATHETER, BILIARY, DIAGNOSTIC13 reports
- Flexima™ Biliary M00539250CATHETER, BILIARY, DIAGNOSTIC12 reports
- Flexima™ Biliary M00539310CATHETER, BILIARY, DIAGNOSTIC9 reports
- Flexima™ Biliary M00539290CATHETER, BILIARY, DIAGNOSTIC7 reports
- Flexima™ Biliary M00539240CATHETER, BILIARY, DIAGNOSTIC6 reports
- Flexima™ Biliary M00539320CATHETER, BILIARY, DIAGNOSTIC6 reports
- Flexima™ Biliary M00539340CATHETER, BILIARY, DIAGNOSTIC4 reports
- Flexima™ Biliary M00539300CATHETER, BILIARY, DIAGNOSTIC3 reports
- Flexima™ Biliary M00539330CATHETER, BILIARY, DIAGNOSTIC3 reports
Recent Flexima Biliary adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 29, 2026Difficult or Delayed Positioning; Difficult to Remove; Device-Device Incompatibility; Positioning Problem
It was reported to Boston Scientific Corporation that a Flexima Biliary Preloaded Stent was to be implanted during a stent placement procedure performed on an unknown date. During the procedure, the guidewire ruptured inside the introducer, resulting in difficulty actuating and properly deploying the Flexima Biliary stent. The stent was deployed at an incorrect location and was not possible to be removed and additional measures were required to address the event. Another of the same device was used to complete the procedure.The patient the experienced hemodynamic instability, progressing to a drop in Hb, and the patient subsequently died.
Patient problems: Insufficient Information
MAUDE report 50936049 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003650 ↗MalfunctionJul 16, 2026Break; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841760 ↗MalfunctionJun 10, 2026Break; Positioning Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS FRACTURED AND COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 25460994 ↗MalfunctionJun 2, 2026Break; Positioning Failure; Use of Device Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED TO TREAT BILIARY STENOSIS IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON APRIL 03, 2026. DURING THE PROCEDURE, WHEN THE STENT PUSHER WAS PULLED, THE CONNECTING WIRE FRACTURED AND THE STENT COULD NOT BE DEPLOYED. FURTHER INFORMATION RECEIVED CONFIRMED THE DAMAGE WAS NOT DUE TO A SUTURE BREAK BUT RATHER AT THE CONNECTION POINT BETWEEN THE DELIVERY SYSTEM AND THE STENT STRUCTURE. ANOTHER FLEXIMA BILIARY PRELOADED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE INSTRUCTIONS FOR USE (IFU): "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE IFU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361657 ↗MalfunctionMay 27, 2026Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SPECIALIST INSERTED THE DEVICE; HOWEVER, WHEN ATTEMPTING TO RELEASE THE STENT, IT WAS NOT POSSIBLE TO DEPLOY. ANOTHER FLEXIMA BILIARY PRELOADED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308386 ↗MalfunctionMay 21, 2026Break; Positioning Failure; Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED TO TREAT STONES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 7 FR BY 7 CM STENT WAS ADVANCED OVER A 0.035" JAGWIRE GUIDEWIRE AND PASSED SMOOTHLY THROUGH THE WORKING CHANNEL. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE STENT FAILED TO RELEASE. THE ENTIRE STENT AND INTRODUCER ASSEMBLY WAS WITHDRAWN, AT WHICH POINT THE INTRODUCER WAS FOUND TO BE BUNCHED. THE GUIDEWIRE COULD NOT BE REMOVED BECAUSE IT REMAINED JAMMED INSIDE THE INTRODUCER, AS THE RELEASE THREAD HAD NOT DISENGAGED. ANOTHER FLEXIMA BILIARY PRELOADED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FIELD FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250425 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED FOR DILATATION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS IMPLANTED; HOWEVER, FOLLOWING PLACEMENT, IT WAS NOTED THAT THE RADIOPAQUE MARKER BAND HAD DETACHED AND REMAINED INSIDE THE PATIENT. THE MARKER BAND WAS LEFT IN SITU, AS THE PHYSICIAN DETERMINED THAT IT WOULD NOT IMPACT THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT, AND NO ADDITIONAL SURGERY OR INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 25167982 ↗InjuryApr 27, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED IN THE COMMON BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING DEPLOYMENT PROCESS, THE INNER GUIDE CATHETER GOT DETACHED. IT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 25009164 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT FRACTURED INTO MULTIPLE PIECES WHILE BEING ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 24987476 ↗MalfunctionApr 16, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED INTO THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE INSTRUCTIONS FOR USE (IFU): IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED. THE USER DID NOT FOLLOW THE IFU. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901375 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT DELIVERY DEVICE WAS PULLED, AND IT WAS NOTICED THE CONNECTING WIRE WAS FRACTURED. THE STENT COULD NOT BE DEPLOYED, AND THE PROCEDURE HAD TO BE COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885679 ↗MalfunctionMar 3, 2026Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, DIFFICULTIES WERE ENCOUNTERED DURING THE DEPLOYMENT PHASE. IMMEDIATELY FOLLOWING THE FINAL POSITIONING OF THE STENT, THE COMPONENTS OF THE DEVICE SEPARATED AND FELL APART. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500605 ↗MalfunctionMar 3, 2026Positioning Failure; Nonstandard Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS INTENDED TO BE IMPLANTED TO TREAT BILE DUCT STONES IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY, AND THE INNER CORE ROLLED UP EASILY WHEN MANIPULATED WITH THE GUIDEWIRE. ANOTHER FLEXIMA BILIARY STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500161 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE GALLBLADDER DURING A GALLSTONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PLASTIC STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 25, 2026: IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE IMPLANTED IN THE GALLBLADDER FOR STONES TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437264 ↗
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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.
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