Epic™ Biliary M00572280Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729896906), received between Apr 30, 2018 and Nov 12, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 19, 2023Use of Device Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Use of Device Problem; Deformation Due to Compressive Stress; 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, 3005099803-2023-03835, 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 THIS REPORT) WAS ALSO DIFFICULT TO ADVANCE THROUGH THE SCOPE, AND THE OUTERSHEATH BECAME BUCKLED AND KINKED. DURING WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349959 ↗
• MalfunctionJul 12, 2023Use of Device Problem; Failure to Advance; Activation, Positioning or Separation Problem; Difficult to Advance; Use of Device Problem; Failure to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-03778, FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 21, 2023, THAT 2 EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE COMMON BILE DUCT AT THE HEPATIC BIFURCATION TO TREAT A MALIGNANT 2 CM KLATSKIN'S TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST EPIC BILIARY STENT (THE SUBJECT OF THIS REPORT) WAS STUCK IN THE WORKING CHANNEL OF THE SCOPE AND COULD NOT BE ADVANCED. THE FIRST STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. A SECOND EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2023-03778) WAS USED, HOWEVER, IT WAS DIFFICULT TO ADVANCE THROUGH THE SCOPE, AND THE DEPLOYMENT CATHETER BECAME BUCKLED AND KINKED. THE SECOND STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO REPORTED PATIENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304827 ↗
• MalfunctionJul 27, 2021Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2021 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT CHOLANGIOCARCINOMA IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING INSERTION, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE SCOPE. THE STENT BEGAN TO DEPLOY AS IT ADVANCED FROM THE SCOPE BEFORE ENTERING THE AMPULLA. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH PLASTIC STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229388 ↗
• MalfunctionSep 25, 2020Premature Activation; Activation, Positioning or Separation Problem; Difficult to Advance; Premature Activation; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 03, 2020 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT STARTED TO DEPLOY WITHOUT MANIPULATION WHILE ADVANCING THROUGH THE SCOPE PRIOR TO ENTERING THE AMPULLA. REPORTEDLY, THE STENT WAS PARTIALLY COVERED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS 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 10586831 ↗
• MalfunctionJun 22, 2020Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 01, 2020 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT A CHOLANGIOCARCINOMA IN THE LEFT HEPATIC DUCT DURING A BILIARY METALLIC STENT BILATERAL PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, CONSIDERABLE FORCE WAS REQUIRED TO MOVE THE THUMB WHEEL DURING THE ATTEMPTED DEPLOYMENT OF THE STENT AND THE STENT FAILED TO FULLY DEPLOY. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. REPORTEDLY, SEVERE INTERFERENCE WAS FELT BETWEEN THE GUIDEWIRE AND DELIVERY SYSTEM DURING WITHDRAWAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181718 ↗
• InjuryJun 27, 2019Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN ENDOSCOPIC EPIC BILIARY STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE BILIARY/ HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS, HEAVILY STRICTURED AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT BY CLICKING THE THUMBWHEEL; HOWEVER, THE STENT STAYED IN THE SHEATH AND DID NOT DEPLOY. THE PHYSICIAN THEN PULLED THE HANDLE TO DEPLOY THE STENT, AND THE STENT STILL FAILED TO DEPLOY. THE STENT AND DELIVERY SYSTEM WAS PULLED OUT FROM THE BILIARY DUCT AND SUDDENLY THE STENT DEPLOYED IN THE DUODENUM. THE STENT WAS REMOVED WITH RAT TOOTH FORCEPS AND THE PROCEDURE WAS DISCONTINUED. THERE WERE NO PATENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. ACCORDING TO THE PHYSICIAN, IT SEEMED LIKE THE STENT WOULD NOT DEPLOY BECAUSE IT DIDN'T HAVE ROOM IN THE DUCT DUE TO IT BEING HEAVILY STRUCTURED AND TORTUOUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741490 ↗
• InjuryApr 30, 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 TO BE USED TO TREAT A MALIGNANT STRICTURE THAT CAUSED HEPATIC OBSTRUCTION DUE TO METASTASIS OF THE CANCER CELLS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED. HOWEVER, RESISTANCE WAS FELT WHEN REMOVING THE DELIVERY SYSTEM FROM THE STENT AND OUT FROM THE COMMON BILE DUCT. IT WAS NOTED THAT THE DELIVERY SYSTEM WAS STUCK/ JAMMED. THE PHYSICIAN GAVE A SUDDEN PULL TO THE DELIVERY SYSTEM AND AS A RESULT, THE INNER CATHETER WAS KINKED AND WAS DETACHED INSIDE THE PATIENT. THE DETACHED PIECE WAS REMOVED WITH GRASPING FORCEPS. THE PATIENT UNDERWENT A FLUOROSCOPY AND THE IMAGES CONFIRMED NO BROKEN PIECE WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONDITION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474130 ↗
• MalfunctionApr 30, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT AN EPIC BILIARY STENT HAS BEEN IMPLANTED IN THE BILE DUCT TO TREAT A HEPATIC PORTAL STENOSIS DUE TO BILE DUCT CANCER DURING A SIDE-BY-SIDE (SBS) BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GUIDEWIRE WAS PLACED IN THE ANTERIOR RIGHT HEPATIC DUCT (B8) AND A SECOND NON- BSC GUIDEWIRE WAS PLACED IN THE LEFT SUPERIOR HEPATIC DUCT (B2). THE STENT ADVANCED INTO THE ANTERIOR RIGHT DUCT (B8) WAS DEPLOYED WITHOUT ISSUE. THE EPIC BILIARY STENT ADVANCED INTO THE LEFT SUPERIOR HEPATIC DUCT (B2) FAILED TO FULLY DEPLOY AFTER THE THUMBWHEEL WAS ROLLED THIRTY TIMES. AN ATTEMPT TO RE-CONSTRAIN THE PARTIALLY DEPLOYED STENT WAS PERFORMED, BUT IT WAS UNSUCCESSFUL. THE HANDLE OF THE DEVICE WAS THEN ACTUATED AND INTENTIONALLY DEPLOYED THE STENT BUT MORE DISTAL THAN THE DESIRED LOCATION. REPORTEDLY, NO FURTHER TREATMENT WAS PERFORMED HOWEVER, CONTINUOUS MONITORING OF THE STENT WILL BE OBSERVED. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473220 ↗