Epic BiliaryRecalls & reported problems across all models
Boston Scientific Corporation · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 95
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 11 models of Epic Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2018 and Jan 26, 2026 — classified as 23 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (39 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 Epic Biliary problems
Device problems
- Activation, Positioning or Separation Problem39
- Material Deformation20
- Difficult to Advance16
- Difficult to Remove16
- Positioning Failure16
- Premature Activation15
- Detachment of Device or Device Component11
- Positioning Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient22
- Foreign Body In Patient4
- Insufficient Information1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Epic Biliary models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Epic™ Biliary M00572340CATHETER, BILIARY, DIAGNOSTIC33 reports
- Epic™ Biliary M00572330CATHETER, BILIARY, DIAGNOSTIC11 reports
- Epic™ Biliary M00572260CATHETER, BILIARY, DIAGNOSTIC10 reports
- Epic™ Biliary M00572290CATHETER, BILIARY, DIAGNOSTIC10 reports
- Epic™ Biliary M00572300CATHETER, BILIARY, DIAGNOSTIC10 reports
- Epic™ Biliary M00572280CATHETER, BILIARY, DIAGNOSTIC9 reports
- Epic™ Biliary M00572240CATHETER, BILIARY, DIAGNOSTIC4 reports
- Epic™ Biliary M00572250CATHETER, BILIARY, DIAGNOSTIC4 reports
- Epic™ Biliary M00572270CATHETER, BILIARY, DIAGNOSTIC2 reports
- Epic™ Biliary M00572230CATHETER, BILIARY, DIAGNOSTIC1 report
- Epic™ Biliary M00572310CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Epic Biliary adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT MALIGNANT BILIARY STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PROXIMAL PART OF THE STENT WAS NOT OPENED. IT WAS NOTED THAT THE STENT WAS ONLY 50% DEPLOYED AND IT WAS CLOSED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24180801 ↗MalfunctionNov 20, 2025Premature Activation; Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT HILAR TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC STENT WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, AS THE STENT EXITED THE SCOPE, IT WAS NOTED THAT IT HAD PARTIALLY DEPLOYED AT THE TIP OF THE DEVICE BEFORE THE DEPLOYMENT PROCESS HAD BEEN INITIATED. THE PREMATURE DEPLOYED STENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610422 ↗MalfunctionNov 12, 2025Activation, Positioning or Separation Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANCY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT BACKLOAD IN THE EPIC BILIARY DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536413 ↗MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THIS REPORT PERTAINS TO ONE OF TWO EPIC BILIARY STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05832 AND 3005099803-2025-05833 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO (2) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A MALIGNANT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON OCTOBER 14, 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING A BILATERAL STENTING PROCEDURE, THE FIRST EPIC STENT (SUBJECT OF THIS REPORT) DID NOT OPEN UP, AND THE SECOND EPIC STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05833) DID NOT OPEN UP AS WELL. THE STENTS WERE REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477905 ↗MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THIS REPORT PERTAINS TO ONE OF TWO EPIC BILIARY STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05832 AND 3005099803-2025-05833 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO (2) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A MALIGNANT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON OCTOBER 14, 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING A BILATERAL STENTING PROCEDURE, THE FIRST EPIC STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05832) DID NOT OPEN UP, AND THE SECOND EPIC STENT (SUBJECT OF THIS REPORT) DID NOT OPEN UP AS WELL. THE STENTS WERE REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477891 ↗MalfunctionJul 16, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN HILUM TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS DIFFICULTY OPERATING THE THUMB WHEEL ON THE DELIVERY SYSTEM, RESULTING IN THE STENT NOT DEPLOYING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER EPIC BILIARY STENT FROM A DIFFERENT LOT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION FINDINGS WHICH REVEALED THE STENT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523764 ↗MalfunctionJun 3, 2025Break; Positioning Failure; Detachment of Device or Device Component; Material Deformation; Break; Positioning Failure; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED TO TREAT AN APPROXIMATELY 3CM MALIGNANT HILAR STRICTURE DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. A PLASTIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED, AND IT WAS OBSERVED THAT THE OUTER BLUE SHEATH WAS BROKEN, AND THE INNER SHEATH WAS KINKED. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137569 ↗MalfunctionApr 24, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE BILIARY TREE TO TREAT A BILE DUCT STRICTURE DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE ADVANCED OVER THE WIRE, BUT IT WOULD NOT PASS, AND THE TIP OF CATHETER DETACHED FROM THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903935 ↗MalfunctionApr 10, 2025Nonstandard Device; Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Difficult to Remove; Defective Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS IMPLANTED IN THE UPPER PART OF THE COMMON BILE DUCT TO TREAT AN OBSTRUCTIVE JAUNDICE DUE TO KLATSKIN TUMOR TYPE I DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS DUE TO THE KLATSKIN TUMOR AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT WAS WIDER AND SHORTER THAN THE LABELED LENGTH. THE STENT REMAINS IMPLANTED SINCE IT ADEQUATELY COVERED THE STENOSIS, BUT DIFFICULTY IN REMOVING THE DELIVERY SYSTEM WAS ALSO ENCOUNTERED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21815676 ↗MalfunctionJan 8, 2025Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST STENT WAS SUCCESSFULLY PLACED IN THE LEFT HILAR DUCT; HOWEVER, THE SECOND STENT COULD NOT BE DEPLOYED AND WHILE PULLING OUT THE STENT, THE HANDLE WAS BROKEN. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21105767 ↗MalfunctionOct 11, 2024Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A BILIARY OBSTRUCTION IN THE BILIARY DUCT CAUSED BY A MALIGNANT STRICTURE ABOVE THE HILAR REGION DURING A BILIARY SELF- EXPANDING METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DEPLOYMENT THUMBWHEEL WAS ROTATED TO DEPLOY THE STENT; HOWEVER, THE SHEATH REMAINED IN POSITION AND THE STENT DID NOT DEPLOY. WHILE REMOVING THE STENT CATHETER, THE SHEATH MOVED, AND THE STENT DEPLOYED PREMATURELY INSIDE THE SCOPE. THE STENT GOT STUCK AND WAS REMOVED TOGETHER WITH THE SCOPE. ANOTHER EPIC BILIARY STENT AND SCOPE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20430282 ↗InjurySep 19, 2024Use of Device Problem; Difficult to Advance; Positioning Problem; Use of Device Problem; Difficult to Advance; Positioning Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE LEFT HEPATIC BILE DUCT TO TREAT A BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE YELLOW LUER LOCK FLUSHING ATTACHMENT WAS NOT REMOVED FROM THE BACK OF THE EPIC DEVICE, AND THE GUIDEWIRE DID NOT COME OUT OF THE EPIC STENT. THE STENT WAS ABLE TO BE FULLY DEPLOYED; HOWEVER, THE STENT WAS DEPLOYED MORE DISTAL TO THE RIGHT HEPATIC DUCT. THE PHYSICIAN USED AN ARGON PLASMA COAGULATION APC TO CUT A PORTION OF THE STENT THAT WAS PLACED IN THE DUODENUM, AND A DIFFERENT STENT WAS PLACED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE CUSTOMER DID NOT REMOVE THE YELLOW LUER LOCK FLUSHING ATTACHMENT FROM THE BACK OF THE EPIC BILIARY STENT. HOWEVER, THE EPIC BILIARY ENDOSCOPIC INSTRUCTIONS FOR USE STATE, "REMOVE THE FLUSHING LUER" THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTIONS FOR USE (
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20262589 ↗MalfunctionJul 1, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE HILAR TO TREAT A 2CM TO 4CM MALIGNANT HILAR STRICTURE DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DUE TO RESISTANCE THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A PLASTIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19650727 ↗InjuryJun 10, 2024Premature Activation; Failure to Advance; Material Deformation; Premature Activation; Failure to Advance; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC ULTRASOUND (EUS) ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL BILIARY STENTING PROCEDURE PERFORMED ON (B)(6), 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED DURING STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST EPIC STENT WAS SUCCESSFULLY PLACED IN THE RIGHT DUCT. HOWEVER, THE SECOND EPIC STENT PLACED IN THE LEFT DUCT WAS NOT ABLE TO CROSS THE STRICTURE AS THE CATHETER WAS KINKED. THE DEVICE WAS REMOVED, AND THE STRICTURE WAS DILATED USING HURRICANE BALLOON. THE SECOND EPIC STENT WAS RE-INTRODUCED AND WAS ABLE TO CROSS THE STRICTURE. THE PHYSICIAN THEN PROCEEDED TO DEPLOY BOTH STENTS, THE EPIC STENT IN THE RIGHT DUCT DEPLOYED SUCCESSFULLY WHILE THE EPIC STENT IN THE LEFT DUCT DID NOT EVEN AFTER COMPLETE ROLLING OF THE THUMB WHEEL. THE SECOND EPIC STENT THEN DEPLOYED IN THE SCOPE WHEN IT WAS BEING REMOVED, AND IT HAD TO BE REMOVED USING FORCEPS. THE PROCEDURE WAS FINALLY COMPLETED WITH A PLASTIC STENT IN THE LEFT DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505675 ↗MalfunctionApr 30, 2024Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT METASTATIC CANCER DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHEN ADVANCING INTO THE WORKING CHANNEL OF THE DUODENOSCOPE, THE STENT PREMATURELY DEPLOYED. THE STENT WAS STUCK IN THE WORKING CHANNEL AND THE INNER SHEATH BROKE OFF. SUBSEQUENTLY, THE STENT WAS RETRIEVED WITH A SCOPE BRUSH. THE PROCEDURE WAS COMPLETED WITH JUST ONE EPIC BILIARY STENT OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19217263 ↗
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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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