Epic™ Biliary M00572300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729896920), received between Feb 17, 2021 and Jan 26, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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.

• 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 ↗
• MalfunctionApr 5, 2024Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; 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 LEFT HEPATIC DUCT TO TREAT A MALIGNANT TUMOR SECONDARY TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED, THE FLUORO IMAGING WAS INSPECTED AND THERE APPEARED TO BE A POSSIBLE FOREIGN BODY FROM THE STENT SYSTEM LEFT IN THE PATIENT. THE DELIVERY CATHETER WAS INSPECTED AFTER REMOVAL AND IT LOOKED LIKE EVERYTHING WAS ON THE SYSTEM THAT SHOULD BE. THE PROCEDURE WAS COMPLETED, AND THE STENT REMAINS IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE IMAGING SHOWED NO FOREIGN BODY INSIDE THE PATIENT, AND THERE WERE NO VISIBLE DAMAGES NOTED TO THE DEVICE DELIVERY SYSTEM WHEN IT WAS INSPECTED OUTSIDE OF THE PATIENT AFTER REMOVAL; HOWEVER, THERE WAS NO INDICATION THAT THE PHYSICIAN WAS RESCINDING THE COMPLAINT. THEREFORE, THIS COMPLAINT WILL BE REPORTED FOR FOREIGN MATERIAL PRESENT IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050226 ↗
• InjuryMar 6, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED BY ROLLING THE THUMB WHEEL; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE DELIVERY SYSTEM. SUBSEQUENTLY, THE WHITE LINING OF THE INNER SHEATH WAS SHEARED OFF AND LEFT HANGING OUT IN THE COMMON BILE DUCT. THE DETACHED INNER SHEATH WAS ATTEMPTED TO BE REMOVED USING RAT-TOOTH FORCEPS AND SNARE, BUT SOME WHITE LINING REMAINED IN THE DUCT. THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18849653 ↗
• MalfunctionNov 6, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; 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 MALIGNANT HILAR STRICTURE DURING A HILAR STRICTURE METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT COULD ONLY BE PARTIALLY DEPLOYED USING THE THUMBWHEEL METHOD. THE STENT WAS ATTEMPTED TO BE DEPLOYED USING THE PULL-GRIP METHOD, BUT IT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND A DIFFERENT STENT WAS USED 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 18076589 ↗
• InjuryMay 11, 2023Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT EPIC BILIARY ENDOSCOPIC STENTS WERE IMPLANTED IN THE LEFT AND RIGHT HEPATIC DUCTS TO TREAT A MALIGNANT HILAR STRICTURE DURING A BILATERAL BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENTS WERE SUCCESSFULLY IMPLANTED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE CATHETER. THE INNER SHEATH BROKE OFF WHILE PULLING OUT THE DELIVERY SYSTEM. THE DETACHED INNER SHEATH WAS REMOVED FROM THE PATIENT USING FORCEPS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED A COMPLETE SEPARATION OF THE INNER SHEATH. THE DISTAL SECTION OF THE INNER SHEATH WAS SEVERELY KINKED AT MORE THAN ONE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912561 ↗
• MalfunctionApr 24, 2023Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 31, 2023 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE HEPATIC DUCT AND COMMON BILE DUCT TO TREAT A CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. ALSO, THE DELIVERY SYSTEM WAS NOTED TO BE BROKEN. THE DEVICE WAS REMOVED; HOWEVER, DEVICE FRAGMENTS WERE LEFT UNRETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC BILIARY STENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT WAS PROVIDED AND IT WAS OBSERVED THAT THE EPIC BILIARY STENT WAS PARTIALLY DEPLOYED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16795437 ↗
• InjuryFeb 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  NOTE: THIS REPORT PERTAINS TO A JAGTOME RX 44 AND AN EPIC BILIARY STENT THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A JAGTOME RX 44 AND TWO EPIC BILIARY ENDOSCOPIC STENTS WERE USED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN EPIC BILIARY STENT WAS SUCCESSFULLY IMPLANTED OVER A NON BSC GUIDEWIRE. A SECOND EPIC BLIARY STENT WAS DEPLOYED OVER A JAGWIRE GUIDEWIRE. HOWEVER, THE JAGWIRE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE PATIENT AS IT WAS STUCK INSIDE THE DEPLOYED STENT IN THE BILE DUCT. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO REMOVE THE GUIDEWIRE ENDOSCOPICALLY WITH RAT TOOTH FORCEPS, BIOPSY FORCEPS, AND A HURRICANE RX TO DILATE THE BILE DUCT. HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE GUIDEWIRE REMAINED STUCK AND WAS COMING OUT OF THE PATIENT'S MOUTH SO THE PATIENT REMAINED IN THE HOSPITAL AND WAS REFERRED TO A SURGEON. AN OPEN SURGERY WAS PERFORMED AND THE GUIDEWIRE WAS CUT IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544231 ↗
• MalfunctionJan 7, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193830 ↗
• InjuryAug 13, 2021Difficult 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) 2021 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED TO TREAT A MALIGNANT HILAR STRICTURE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THERE WAS RESISTANCE WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED. THE PHYSICIAN PULLED ON THE CATHETER WITH FORCE IN AN ATTEMPT TO REMOVE THE DELIVERY SYSTEM UNTIL THE PHYSICIAN HEARD THE DEVICE BREAK AND IT WAS OBSERVED ENDOSCOPICALLY THAT THE ORANGE TRANSITION ZONE OF THE INNER SHEATH BROKE AND WAS STUCK INSIDE THE CBD. THE PHYSICIAN ATTEMPTED TO REMOVE THE INNER SHEATH WITH RAT TOOTH FORCEPS, A SNARE, AND BIOPSY FORCEPS BUT ALL WERE UNSUCCESSFUL AND THE INNER SHEATH REMAINS INSIDE THE PATIENT. REPORTEDLY, THE ORIGINAL STENT REMAINS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319100 ↗
• MalfunctionFeb 17, 2021Failure to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 27, 2021 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED STENT-IN-STENT IN THE COMMON BILE DUCT TO TREAT A BILE DUCT CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY INSERTING THE GUIDEWIRE THROUGH THE STENT. SUBSEQUENTLY, SLIGHT RESISTANCE WAS FELT WHEN INSERTING THE DELIVERY SYSTEM INTO THE COMMON BILE DUCT. REPORTEDLY, THE DELIVERY SYSTEM WAS ADVANCED WITH FORCE AND THE STENT PARTIALLY DEPLOYED ABOUT 1 CM. THE STENT WAS UNABLE TO ADVANCE FURTHER INTO THE BILE DUCT AND THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. ANOTHER EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED 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 11338933 ↗