Epic™ Biliary M00572260Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729896883), received between Jul 22, 2019 and Jul 16, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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.

• 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 ↗
• 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 ↗
• InjuryNov 9, 2023Device Contamination with Chemical or Other Material; Activation Failure; Device Contamination with Chemical or Other Material; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-06025, 3005099803-2023-06026 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, A "WHITE BAND OR MATERIAL" WAS NOTED ON THE DISTAL END OF THE STENT CAUSING THE STENT BEING UNABLE TO EXPAND DESPITE MULTIPLE ATTEMPTS. A CANNULA AND HURRICANE BALLOON WERE USED TO FACILITATE THE EXPANSION OF THE STENT; HOWEVER, THE HURRICANE BALLOON WAS UNABLE TO ADVANCE. EVENTUALLY, THE STENT WAS ABLE TO EXPAND AND ANOTHER EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED, THUS, THE STENT WAS THEN REMOVED WITH FORCEPS. SUBSEQUENTLY, ANOTHER EPIC BILIARY STENT WAS DEPLOYED BUT THE SAME ISSUE WAS NOTED BUT WAS EVENTUALLY ABLE TO EXPAND AFTER A HURR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100954 ↗
• InjuryNov 8, 2023Device Contamination with Chemical or Other Material; Activation Failure; Device Contamination with Chemical or Other Material; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-06025 AND 3005099803-2023-06027 FOR THE ASSOCIATED DEVICE INFORMATION. DURING THE PROCEDURE, AN EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, A "WHITE BAND OR MATERIAL" WAS NOTED ON THE DISTAL END OF THE STENT CAUSING THE STENT BEING UNABLE TO EXPAND DESPITE MULTIPLE ATTEMPTS. A CANNULA AND HURRICANE BALLOON WERE USED TO FACILITATE THE EXPANSION OF THE STENT; HOWEVER, THE HURRICANE BALLOON WAS UNABLE TO ADVANCE. EVENTUALLY, THE STENT WAS ABLE TO EXPAND AND ANOTHER EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED, THUS, THE STENT WAS THEN REMOVED WITH FORCEPS. SUBSEQUENTLY, ANOTHER EPIC BILIARY STENT WAS DEPLOYED BUT THE SAME ISSUE WAS NOTED BUT WAS EVENTUALLY ABLE TO EXPAND AFTER A HURRICANE BALLOON WAS USED TO BREAK THE "WHITE BAND OR MATERIAL". CONSEQUENTLY, THESE PROBLEMS PROLONGED THE PROCEDURE TO 45 MINUTES. THE TWO EPIC BILIARY STENTS REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095198 ↗
• InjuryNov 8, 2023Device Contamination with Chemical or Other Material; Activation Failure; Device Contamination with Chemical or Other Material; Activation Failure

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-06025, 3005099803-2023-06026 AND 3005099803-2023-06027 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, A "WHITE BAND OR MATERIAL" WAS NOTED ON THE DISTAL END OF THE STENT CAUSING THE STENT BEING UNABLE TO EXPAND DESPITE MULTIPLE ATTEMPTS. A CANNULA AND HURRICANE BALLOON WERE USED TO FACILITATE THE EXPANSION OF THE STENT; HOWEVER, THE HURRICANE BALLOON WAS UNABLE TO ADVANCE. EVENTUALLY, THE STENT WAS ABLE TO EXPAND AND ANOTHER EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED, THUS, THE STENT WAS THEN REMOVED WITH FORCEPS. SUBSEQUENTLY, ANOTHER EPIC BILIARY STENT WAS DEPLOYED BUT THE SAME ISSUE WAS NOTED BUT WAS EVENTUALLY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095165 ↗
• MalfunctionFeb 9, 2023Premature Activation; Use of Device Problem; Premature Activation; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY AFTER APPROXIMATELY 12 CLICKS ON THE THUMB WHEEL. WHILE REMOVING THE DELIVERY CATHETER, THE STENT POPPED OUT, AND A PART OF THE STENT WAS PREMATURELY DEPLOYED IN THE COMMON BILE DUCT AND THE OTHER PART WAS DEPLOYED IN THE SCOPE. THE STENT WAS REMOVED FROM THE PATIENT TOGETHER WITH THE SCOPE, 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 16342084 ↗
• MalfunctionSep 7, 2022Positioning 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 THE COMMON BILE DUCT TO TREAT A CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT HAS A TIGHT STRICTURE THROUGH THE HEPATIC DUCT. THE PATIENT 'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE EPIC BILIARY STENT THROUGH THE PREVIOUSLY IMPLANTED EPIC BILIARY STENT; HOWEVER, THE EPIC BILIARY STENT NEVER UNSHEATHED. THE EPIC BILIARY STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND A DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS EXPECTED TO FULLY RECOVER AT THE END OF THE PROCEDURE. NOTE: THE USER INTENTIONALLY CUT THE DEVICE AFTER THE PROCEDURE TO CONFIRM THE STENT WAS PRESENT INSIDE THE DELIVERY SYSTEM. SUBSEQUENTLY, THE STENT JUMP OFF AND FELL TO THE FLOOR. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE STENT WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373421 ↗
• InjuryJun 21, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION GUIDEWIRE AND TWO EPIC BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE EPIC BILIARY STENTS WERE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DUE TO CHOLANGIOCARCINOMA. THE PATIENT'S ANATOMY WAS REPORTED TO BE TIGHT. DURING THE PROCEDURE, TWO 6X100MM EPIC BILIARY STENTS WERE SUCCESSFULLY IMPLANTED BILATERALLY AT THE HEPATIC DUCT BIFURCATION. THE PHYSICIAN CHOSE TO PLACE ONE OF THE 6X100MM EPIC BILIARY STENTS MORE PROXIMAL WITHIN THE DUCT. A 6X60MM EPIC BILIARY STENT WAS THEN PLACED INSIDE THE MORE PROXIMAL 6X100MM EPIC BILIARY STENT TO BRIDGE THE AMPULLA AND HAVE THE STENT COME OUT TRANSPAPILLARY. UPON REMOVAL OF THE DELIVERY SYSTEM OF THE 6X60MM EPIC BILIARY STENT, THE DISTAL TIP OF THE CATHETER DETACHED INSIDE THE PATIENT. UNDER ENDOSCOPIC VIEW IT WAS NOTED THAT THE ORANGE FLOATING BUMPER OF THE INNER SHAFT WAS DISLODGED AND GOT STUCK IN THE DISTAL COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14759862 ↗
• MalfunctionFeb 17, 2022Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAN AN EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED IN THE LEFT HEPATIC DUCT TO TREAT A 2CM STRICTURE DUE TO BILE DUCT CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT DUE TO STRICTURE BUT NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE GUIDEWIRE GOT STUCK AND IT WAS DIFFICULT TO REMOVE THE GUIDEWIRE AND THE DELIVERY SYSTEM FROM THE PATIENT. THE PHYSICIAN FORCEFULLY PULLED THE WIRE AND DELIVERY SYSTEM; THE HYDROPHILIC PORTION OF THE GUIDEWIRE STRIPPED OFF WHICH REMAINED IN THE PATIENT. THE ORIGINAL STENT REMAINS 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 13550253 ↗
• MalfunctionJul 22, 2019Difficult 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) 2019 THAN AN ENDOSCOPIC EPIC BILIARY STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT METASTATIC LESION IN THE LEFT INTRAHEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, DURING DELIVERY SYSTEM REMOVAL, THE INNER CATHETER BROKE. THE BROKEN INNER CATHETER WAS STUCK IN SCOPE, LOCKED IN ELAVATOR AND WAS REMOVED. NO PIECE OF THE CATHETER WAS LEFT INSIDE THE PATIENT. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812841 ↗