Epic™ Biliary M00572290Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729896913), received between Apr 26, 2018 and Nov 20, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionJul 19, 2023Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-03775, 3005099803-2023-03778, 3005099803-2023-03835, AND 3005099803-2023-03836 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT FOUR (4) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE COMMON BILE DUCT AT THE HEPATIC BIFURCATION TO TREAT A 2 CM MALIGNANT KLATSKIN'S TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SELF-EXPANDABLE METALLIC STENT (SEMS) IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, TWO EPIC BILIARY STENTS WERE ATTEMPTED TO BE PLACED BILATERALLY AT THE SAME TIME. THE FIRST EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03775) WAS LODGED IN THE WORKING CHANNEL OF THE SCOPE, THE DELIVERY SYSTEM COULD NOT BE ADVANCED, AND THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE SECOND EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03778) WAS ALSO DIFFICULT TO ADVANCE THROUGH THE SCOPE, AND THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350073 ↗
• MalfunctionJul 19, 2023Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-03775, 3005099803-2023-03778, 3005099803-2023-03835, FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2023, THAT FOUR (4) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE COMMON BILE DUCT AT THE HEPATIC BIFURCATION TO TREAT A 2 CM MALIGNANT KLATSKIN'S TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SELF-EXPANDABLE METALLIC STENT (SEMS) IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, TWO EPIC BILIARY STENTS WERE ATTEMPTED TO BE PLACED BILATERALLY AT THE SAME TIME. THE FIRST EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03775) WAS LODGED IN THE WORKING CHANNEL OF THE SCOPE, DELIVERY SYSTEM COULD NOT BE ADVANCED, AND THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE SECOND EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03778) WAS ALSO DIFFICULT TO ADVANCE THROUGH THE SCOPE, AND THE OUTER SHEATH BECAME BUCKLED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349950 ↗
• InjuryJun 29, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC BILIARY STENT ACCIDENTALLY DEPLOYED OUTSIDE THE AMPULLA. THERE WAS NO VISIBLE DAMAGE TO THE EPIC BILIARY STENT, WHICH REMAINED IMPLANTED. A 6CM WALLFLEX UNCOVERED STENT WAS IMPLANTED TO BRIDGE THE AMPULLA TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14858708 ↗
• MalfunctionApr 13, 2021Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER EPIC BILIARY STENT WAS IMPLANTED 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 RESULTS WHICH REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657007 ↗
• MalfunctionNov 5, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN EPIC BILIARY STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE DUE TO BILE DUCT CANCER DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED IN THE LOWER PART OF THE BILE DUCT. THE HANDLE WAS ROTATED BUT THE STENT COULD NOT BE DEPLOYED. REPORTEDLY, THE STENT SUDDENLY BEGAN TO DEPLOY, AND A LONG PART OF THE STENT CAME OUT IN THE DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT AND ANOTHER EPIC BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039543 ↗
• InjuryJun 13, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN EPIC BILIARY STENT HAS BEEN IMPLANTED TO TREAT A STENOSIS IN THE BILE DUCT DUE TO GALL BLADDER CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND SUBSEQUENT TO FLUSHING, AN ENDOSCOPE WAS INSERTED INSIDE THE PATIENT AND A GUIDEWIRE WAS PLACED. THE STENT WAS ADVANCED INTO THE TARGET SITE AND WAS ATTEMPTED TO BE DEPLOYED BY ROTATING THE THUMBWHEEL, HOWEVER, THE OUTER CATHETER DID NOT MOVE AND THE STENT COULD NOT BE DEPLOYED. AFTER FULLY ROTATING THE THUMBWHEEL, THE STENT STILL FAILED TO DEPLOY. WHILE REMOVING THE DELIVERY SYSTEM, THE STENT WAS SUDDENLY RELEASED WITH ABOUT 4 CM OF THE STENT HANGING OUT FROM THE PAPILLA. AN ARGON PLASMA COAGULATION WAS PERFORMED TO TRIM THE PORTION OF THE STENT PART OUTSIDE THE PAPILLA AND THE REMAINING STENT WAS LEFT IMPLANTED INSIDE THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE AND NO ADDITIONAL TREATMENT HAS BEEN PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7598623 ↗
• InjuryApr 26, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN EPIC BILIARY STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE MID COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE DELIVERY SYSTEM WAS STUCK DURING WITHDRAWAL. THE GUIDEWIRE AND THE DELIVERY SYSTEM WERE PULLED OUT TOGETHER. WHILE PULLING OUT THE DELIVERY SYSTEM, THE INNER CATHETER SNAPPED. A PORTION OF THE INNER CATHETER DETACHED AND REMAINED WITHIN THE EPIC STENT. THE DETACHED PIECE OF THE INNER CATHETER WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE EPIC STENT REMAINED IN THE INTENDED LOCATION WITH THE PATIENT AND AN 8X80 WALLFLEX BILIARY UNCOVERED STENT WAS PLACED INSIDE THE EPIC BILIARY STENT AS A BRIDGE TO ENSURE PROPER DRAINAGE. 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 7466518 ↗