Axios™ M00553650Recalls & reported problems

Summary

The FDA's MAUDE database contains 338 adverse event reports that list this exact device (DI 08714729904595), received between Dec 7, 2016 and Sep 16, 2026 — classified as 5 deaths, 180 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (91 reports).

2 FDA recall records name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

   Z-1025-2025 · Root cause: Process control · FDA record ↗

2. Dec 1, 2020Terminated

   The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity

   Z-0774-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 338 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Use of Device Problem; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788059 ↗
• InjurySep 10, 2026Difficult or Delayed Positioning; Use of Device Problem; Positioning Problem

  It was reported to Boston Scientific Corporation that a Hot Axios was to be implanted in the bile duct to treat stones in the bile duct during an Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) procedure performed on (b)(6) 2026. During the procedure, the physician encountered difficulty in deploying the Axios second flange. The stent deployed at an incorrect location, and the patient was perforated. The patient then underwent a Laparoscopic assisted ERCP. The stent was removed, and the perforation was addressed using clips.The patient was reported to be stable following the procedure.Note: It was reported that the Axios stent was attempted to be implanted to treat stones in bile duct. However, per the AXIOS Stent and Electrocautery-Enhanced Delivery System Directions for Use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts equal to or greater than 6 cm in size and walled-off necrosis equal to or greater than 6 cm in size that are adherent to the gastric or bowel wall. The device is not indicated for stones.

  Patient problems: Perforation

  MAUDE report 50718904 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Obstruction/Occlusion; Vomiting

  MAUDE report 50698364 ↗
• MalfunctionAug 17, 2026Positioning Failure; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278459 ↗
• MalfunctionJun 29, 2026Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRICALLY TO TREAT A CYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. THE PROCEDURE WENT WELL AND AS EXPECTED UNTIL THE LAST STEP. THE AXIOS FLANGE WAS DEPLOYED AND IN THE WORKING CHANNEL OF THE SCOPE, BUT WHEN THE PHYSICIAN PULLED THE SCOPE BACK IT PULLED THE STENT OUT OF PLACE. THE PHYSICIAN BELIEVES THAT THE SHEATH WAS NOT COMPLETELY OFF OF THE STENT AND STILL KEEPING IT ATTACHED. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661337 ↗
• MalfunctionJun 29, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PROXIMAL FLANGE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT DID NOT DEPLOY AND REMAINED WITHIN THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659546 ↗
• MalfunctionJun 4, 2026Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO TREAT A PANCREATIC PSEUDOCYST FOR DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE STENT WAS POSITIONED ABNORMALLY, HAVING MIGRATED INTO THE CYST. A FOLLOW-UP REMOVAL IS PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392692 ↗
• InjuryJun 1, 2026Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DISTAL FLANGE DEPLOYED SUCCESSFULLY; HOWEVER, THE PROXIMAL FLANGE COULD NOT BE DEPLOYED DESPITE FULL ADVANCEMENT OF THE DEPLOYMENT HUB. THE PHYSICIAN ATTEMPTED MULTIPLE MANIPULATIONS TO FACILITATE DEPLOYMENT; HOWEVER, THE STENT WAS INADVERTENTLY FULLY DEPLOYED INTO THE CYSTIC COLLECTION. USING GUIDEWIRE ACCESS, A SECOND AXIOS STENT WAS PLACED THROUGH THE INITIALLY DEPLOYED AXIOS STENT TO ACT AS A TUNNEL AND FACILITATE TRANSGASTRIC DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353413 ↗
• MalfunctionMay 25, 2026Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED HAVING A HARD TIME REMOVING THE INTERIOR DELIVERY SYSTEM SPECIFICALLY THE NOSE CONE, AFTER DEPLOYMENT. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM SUCCESSFULLY AND THE DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273266 ↗
• MalfunctionMay 19, 2026Positioning Failure; Use of Device Problem

  THIS REPORT PERTAINS TO ONE OF TWO HOT AXIOS DEVICES USED IN THE SAME PATIENT. REFER TO TRACKWISE #(B)(4) AND TRACKWISE #(B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED IN A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DISTAL FLANGE OF THE FIRST AXIOS STENT FAILED TO DEPLOY. THE SAME ISSUE WAS ALSO REPORTED WITH ANOTHER DEVICE OF THE SAME TYPE. CONSEQUENTLY, THE PHYSICIAN PLACED AN AGILE ESOPHAGEAL STENT AFTER THE 2 FAILED AXIOS STENTS. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE THROUGH THE INITIAL PUNCTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221787 ↗
• MalfunctionMay 15, 2026Positioning Failure; Use of Device Problem

  THIS REPORT PERTAINS TO ONE OF TWO HOT AXIOS DEVICES USED IN THE SAME PATIENT. REFER TO TRACKWISE #22766761 AND TRACKWISE #22767798 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED IN A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DISTAL FLANGE OF THE FIRST AXIOS STENT FAILED TO DEPLOY. THE SAME ISSUE WAS ALSO REPORTED WITH ANOTHER DEVICE OF THE SAME TYPE. CONSEQUENTLY, THE PHYSICIAN PLACED AN AGILE ESOPHAGEAL STENT AFTER THE 2 FAILED AXIOS STENTS. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE THROUGH THE INITIAL PUNCTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191495 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO FACILITATE PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. AFTER THE YELLOW SAFETY CLIP WAS REMOVED, THE ARROW AND LATCH WOULDN'T MOVE RIGHT OR SLIDE OVER. TO TRY TO RELEASE THE STENT, THE PHYSICIAN TRIED TO MOVE THE NOTCH OVER MULTIPLE TIMES VERY HARD, BUT IT WOULD NOT BUDGE AND THE ATTEMPT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145186 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO FACILITATE PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. AFTER THE YELLOW SAFETY CLIP WAS REMOVED, THE ARROW AND LATCH WOULDN'T MOVE RIGHT OR SLIDE OVER. TO TRY TO RELEASE THE STENT, THE PHYSICIAN PUSHED VERY HARD, BUT IT WOULD NOT BUDGE AND THE ATTEMPT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145180 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO FACILITATE DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT HANDLE BROKE AND THERE WERE UNABLE TO DEPLOY THE FIRST FLANGE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144899 ↗
• MalfunctionMay 11, 2026Positioning Failure; Use of Device Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE ESOPHAGUS AREA TO PERFORM AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN HAD A PROBLEM WITH DEPLOYING THE STENT, THE TIP OF THE DEPLOYMENT SYSTEM GOT BENT, AND IT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED IN THE ESOPHAGUS AREA TO PERFORM AN ESOPHAGOGASTRODUODENOSCOPY (EGD). HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM IN SIZE AND WALLED-OFF NECROSIS 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE IMPLANTED IN THE ESOPHAGUS AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144891 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSDUODENAL TO TREAT PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT HAD HEAVY RESISTANCE WHEN DEPLOYING THE FIRST FLANGE AND THE HANDLE BROKE. ADDITIONALLY, THE PHYSICIAN REMOVED THE STENT FROM THE SCOPE AND TRIED A NEW AXIOS STENT (SUBJECT OF THIS REPORT) BUT HAD THE SAME OUTCOME. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE (3RD STENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144874 ↗
• MalfunctionMay 11, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE TRANSGASTRIC TO TREAT PANCREATIC PSEUDOCYST DURING A PANCREATIC CYSTENTEROSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE DISTAL FLANGE FAILED TO DEPLOY. ADDITIONALLY, THE PHYSICIAN TRIED TO NEUTRALIZE THE SCOPE, BUT IT STILL DID NOT WORK. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144870 ↗
• MalfunctionMay 11, 2026Positioning Failure; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO RETRIEVE PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT WAS BEING PLACED USING THE OVER-THE-GUIDEWIRE TECHNIQUE. HOWEVER, THE BILIARY WIRE COATING BEGAN TO SHEAR OFF, WHICH INTERFERED WITH THE PROPER DEPLOYMENT OF THE AXIOS. ULTIMATELY, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144867 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSDUODENAL TO TREAT PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT HAD HEAVY RESISTANCE WHEN DEPLOYING THE FIRST FLANGE AND THE HANDLE BROKE (SUBJECT OF THIS REPORT). ADDITIONALLY, THE PHYSICIAN REMOVED THE STENT FROM THE SCOPE AND TRIED A NEW AXIOS STENT BUT HAD THE SAME OUTCOME. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE (3RD STENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144864 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE STENT EXPERIENCED AN ISSUE DURING DEPLOYMENT. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144863 ↗
• MalfunctionMay 11, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO TREAT WALLED OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT INTERNAL FLANGE WOULD NOT OPEN. ADDITIONALLY, THE PHYSICIAN REMOVED THE STENT AND TRIED TO DEPLOY IT OUTSIDE THE PATIENT, BUT IT WOULD STILL NOT OPEN. THE STENT AS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING A COLD AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144862 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANGASTRIC TO RETRIEVE A PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT DEPLOYMENT HUB BROKE DURING DEPLOYMENT. THE PHYSICIAN REMOVED THE CATHETER; THE STENT WAS REMOVED FULLY COVERED BY OUTER SHEATH AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144861 ↗
• MalfunctionMay 11, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANGASATRIC TO PANCREAS TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) TRANSLUMINAL STENT PLACING PROCEDURE PERFORMED ON AN UNKNOWN DATE DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE AXIOS DELIVERY CATHETER THROUGH A 3.7 MM WORKING CHANNEL OF A LINEAR EUS SCOPE AND POSITIONED THE DEVICE AT THE TARGET SITE. FOLLOWING THE INITIAL PUNCTURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE STENT WOULD NOT DEPLOY FROM THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER AXIOS STENT OF THE SAME MODEL, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144421 ↗
• MalfunctionMay 11, 2026Positioning Failure; Nonstandard Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANGASTRIC TO FACILITATE A PSEUDOCYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE CATHETER LOOKED SLIGHTLY BENT AND THEN STILL TRIED TO USE IT AND HAD A PROBLEM WHEN DEPLOYMENT; IT DID NOT DEPLOY. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT "UPON OPENING THE PACKAGE THE CATHETER LOOKED SLIGHTLY BENT. PHYSICIAN STILL TRIED TO USE THE STENT, AND IT WOULDN'T DEPLOY." PER THE IFU, "BEFORE USE, EXAMINE THE OUTER SURFACE OF DEVICES WHICH ARE INTENDED TO BE INSERTED INTO A PATIENT OR USED DURING PROCEDURE. DO NOT USE A DEVICE THAT HAS UNINTENDED ROUGH SURFACES, SHARP EDGES OR PROTRUSIONS WHICH MAY CAUSE HARM. CUT, BURNED OR DAMAGED DEVICE INSULATION MAY CAUSE UNSAFE CURRENTS IN EITHER PATIENT OR OPERATOR." THE USER DID NOT FOLLOW THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144420 ↗
• MalfunctionMay 11, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE PANCREAS TO FACILITATE FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, STENT FIRST FLANGE DID NOT DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144419 ↗