Axios™ M00553690Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00191506008093), received between Sep 10, 2021 and Mar 11, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 reports).

2 FDA recall records name this device's identifier, 2 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 19, 2025Open, Classified

   Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

   Z-1160-2026 · Root cause: Process control · FDA record ↗

2. 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-1029-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Use of Device Problem; Detachment of Device or Device Component; 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 IMPLANTED TRANSDUODENAL TO FACILITATE GALLBLADDER DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, STENT DEPLOYMENT PROCEEDED NORMALLY; HOWEVER, AFTER DEPLOYMENT THE NOSE CONE DETACHED AND HAD TO BE MANUALLY REMOVED FROM THE PATIENT USING FORCEPS. THE STENT WAS REPORTED TO BE CURRENTLY IMPLANTED; THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE DESPITE THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED FULLY RECOVERED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO FACILITATE GALLBLADDER DRAINAGE. 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 OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571097 ↗
• InjuryDec 24, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A CHOLEDOCHO-DUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS DISTAL FLANGE WAS NOT OPENING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23889513 ↗
• InjuryDec 3, 2025Positioning Failure; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Retraction Problem; Use of Device 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 TRANSDUODENAL TO TREAT A MALIGNANT BILIARY OBSTRUCTION THROUGH A BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN EVEN THOUGH THE INITIAL STENT DEPLOYMENT HAD BEEN COMPLETED (STEP 2) AND THE AUDIBLE "CLICK" WAS HEARD. ADDITIONALLY, THE STENT DEPLOYMENT HUB WAS VERY DIFFICULT TO DEPLOY, A LOT OF RESISTANCE WAS FELT. IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS REQUIRED TO COMPLETE THE PROCEDURE. 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 TO TREAT A MALIGNANT BILIARY OBSTRUCTION DURING A CHOLEDOCHODUODNOSTOMY 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 OR LARGER IN SIZE WITH AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706184 ↗
• InjurySep 16, 2025Failure to Advance; Activation, Positioning or Separation Problem; Positioning Problem; Activation Failure; Failure to Advance; Activation, Positioning or Separation Problem; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSDUODENAL FOR DRAINAGE OF THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY. AN ATTEMPT WAS MADE TO REPOSITION THE STENT WITHIN THE DUCT AND REDEPLOY THE DISTAL FLANGE, BUT IT WAS UNABLE TO ADVANCE DUE TO THE OPPOSITE WALL POSITION. REPORTEDLY, THE STENT WOULD NOT DEPLOY DUE TO ANGLE OF PUNCTURE IN BILE DUCT. A GUIDEWIRE WAS THEN PLACED THROUGH THE DELIVERY SYSTEM TO FACILITATE AN EXCHANGE FOR A NEW STENT, AND THE STENT WAS REMOVED PARTIALLY DEPLOYED. THE RETRIEVED STENT WAS ULTIMATELY DEPLOYED OUTSIDE THE PATIENT, AND 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 23069400 ↗
• InjuryFeb 20, 2025Difficult or Delayed Activation; Migration; Difficult or Delayed Activation; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT CHOLECYSTITIS DURING A ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS SLOW TO EXPAND, BUT THE PHYSICIAN WAS ABLE TO OPEN IT BY MANIPULATING THE CATHETER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. ONE DAY AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THERE IS AIR AND THAT THE STENT HAD MIGRATED, WITH THE DISTAL FLANGE LOCATED IN THE STOMACH AND THE PROXIMAL FLANGE IN THE PERITONEUM. THE STENT WAS SUCCESSFULLY REMOVED, AND TWO CLIPS WERE PLACED TO CLOSE THE PUNCTURE SITE. THE PATIENT'S CONDITION IMPROVED FOLLOWING THE REMOVAL OF THE STENT.

  Patient problems: Flatus; Pain; Perforation

  MAUDE report 21422528 ↗
• InjuryDec 26, 2024Positioning Failure; Mechanical Problem; Use of Device Problem; Positioning Failure; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE HANDLE DID NOT UNLOCK, WHICH RESULTED IN THE STENT BEING UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. HOWEVER, PER 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 IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED FOR BILIARY DRAINAGE. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2024*** IT WAS REPORTED THAT THE STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020783 ↗
• InjuryJul 2, 2024Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT FOR THE TREATMENT OF A METASTATIC CHOLANGIOCARCINOMA DURING A CHOLEDOCHO DUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED, AND THE HANDLE BROKE. THE DEVICE WAS REMOVED, AND THE PUNCTURE WAS CLOSED USING AN OVESCO CLIP. THE PATIENT EXPERIENCED BILE LEAK AND WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED TO ADDRESS THE BILE LEAK AND A FULLY COVERED BILIARY METAL STENT WAS PLACED IN THE COMMON BILE DUCT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO WEEKS LATER. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED IN THE BLIE DUCT TO TREAT A METASTATIC CHOLANGIOCARCINOMA. HOWEVER, PER 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 IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE F

  Patient problems: Biliary Leak

  MAUDE report 19655180 ↗
• MalfunctionAug 24, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO PANCREAS TO TREAT A PSEUDOCYST DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN STENT DEPLOYMENT WAS ATTEMPTED, THE DISTAL FLANGE OF THE AXIOS STENT WAS UNABLE TO DEPLOY. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611047 ↗
• MalfunctionJun 1, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 05, 2023 THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO PANCREAS TO TREAT A WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS STENT WAS UNABLE TO DEPLOY. THE AXIOS STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10X10 AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037195 ↗
• InjuryMay 24, 2023Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE GALLBLADDER FOR GALLBLADDER DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AXIOS CAUTERY WAS PERFORMED, AND THE PHYSICIAN PROCEEDED ON DEPLOYING THE FIRST FLANGE; HOWEVER, THE PHYSICIAN DID NOT HEAR THE LOCK CLICK AND NOTED THE HANDLE MOVING TO STEP 4. THE PHYSICIAN ATTEMPTED TO MOVE THE CATHETER BACK DOWN, BUT THE STENT FULLY DEPLOYED INSIDE THE GALLBLADDER. THE STENT REMAINS IMPLANTED AND A 10X10 MM AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THE STENT WILL BE REMOVED TOGETHER WITH THE 10X10MM AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE SIZE OF THE SCOPE USED WAS 2.8 MM WORKING CHANNEL. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE WORKING CHANNEL OF THE SCOPE SHOULD BE 3.7MM OR LARGER. THE STENT IS NOT COMPATIBLE WITH A SCOPE WITH A WORKING CHANNEL SIZE OF 2.8MM. IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR GALLBLADDER DRAINAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994576 ↗
• InjuryMay 16, 2023Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO COMMON BILE DUCT TO TREAT A CHOLECHODUODENOSTOMY DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION.DURING THE PROCEDURE, THE STENT'S FIRST FLANGE WAS DEPLOYED INCORRECTLY INTO THE PERITONEAL CAVITY. THE AXIOS STENT WAS PARTIALLY DEPLOYED WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN FELT UNSAFE TO PROCEED.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS TO BE IMPLANTED FOR CHOLEDOCHODUODENOSTOMY. 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 S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940883 ↗
• InjuryJul 1, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH BILE DUCT DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN DISCONNECTED THE CAUTERY AFTER COMPLETING STEP 1; HOWEVER, THE "HUB HANDLE SPLIT DOWN THE MIDDLE". THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. 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 >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884855 ↗
• InjurySep 10, 2021Difficult to Remove; Human-Device Interface Problem; Migration; Difficult to Remove; Human-Device Interface Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 18, 2021 THAT A HOT AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A 7CM PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE AXIOS REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, IT WAS NOTED THAT THE STENT MIGRATED INTO THE COLLECTION. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT USING A RAT TOOTH FORCEPS; HOWEVER, THE STENT WAS UNABLE TO BE VISUALIZED DUE TO TISSUE OVERGROWTH AND COULD NOT BE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO REMOVE SOME OF THE TISSUE TO EXPOSE THE STENT FOR REMOVAL; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. THE PATIENT WAS REFERRED TO SURGERY AND A DISTAL PANCREATECTOMY WAS PERFORMED THE SAME DAY TO REMOVE THE STENT. THE PATIENT EXPERIENCED PATIENT COMPLICATIONS AND WAS ADMITTED TO THE HOSPITAL FOR THE SURGERY TO REMOVE THE STENT AND RECOVERY. REPORTEDLY, THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Insufficient Information

  MAUDE report 12453618 ↗