Axios™ M00553640Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 08714729904588), received between Nov 17, 2016 and Sep 23, 2026 — classified as 2 deaths, 71 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (32 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-1024-2025 · 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-0773-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Positioning Failure; 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 in the Gallbladder to treat Cholecystitis during an Endoscopic Ultrasound Gallbladder Drainage procedure performed on (b)(6)2026.During the procedure, the physician reported that 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.Note: It was reported that the entire handle was rotated. However, the Hot Axios Stent and Delivery System Instructions for Use state "Rotate the winged Luer lock clockwise to secure the delivery system handle to the echoendoscope." The physician did not follow the steps cited in the Instructions For Use (IFU).Note: It was reported that the size of the scope used was 3.2 mm working channel. However, per the AXIOS Stent and Electrocautery- Enhanced Delivery System Instructions 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 3.2 mm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868657 ↗
• MalfunctionSep 3, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600004 ↗
• MalfunctionAug 31, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533765 ↗
• MalfunctionAug 6, 2026Entrapment of Device; Mechanical Problem; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162961 ↗
• InjuryAug 4, 2026Use 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 in the Duodenal bulb to treat acute cholecystitis during an Endoscopic Ultrasound (EUS) procedure performed on (B)(6) 2026. It was reported that the patient had an axios stent implanted and a Cook 7 Fr x 4cm double pigtail through stent went through the Axios stent. The patient came back for a follow up and Axios removed with a rat tooth forceps when the physician noticed that there was severe ulceration around the contralateral wall of duodenum. The patient was treated with High Dose of PPI (proton pump inhibitor). It was also reported that the patient was not suitable for laparoscopic cholecystectomy due to many underlying conditions, so the GI was consulted for Axios placement. 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 Pancreatic cystic gastrectomy with Gallbladder drainage - acute cholecystitis procedure. However, according to the AXIOS Stent and Electrocautery-Enhanced Delivery System Instructions for Use, the stent

  Patient problems: Ulcer

  MAUDE report 50128666 ↗
• InjuryJul 30, 2026Break; Difficult to Remove; Migration

  It was reported to Boston Scientific Corporation that an Axios Stent and Electrocautery Enhanced Delivery System was to be implanted transgastric to the gallbladder for the treatment of acute cholecystitis during an Endoscopic Ultrasound (EUS) - guided gallbladder drainage procedure performed on an unknown date. During an endoscopic procedure performed on (b)(6) 2026, to remove a previously implanted device and replace the double-pigtail stent with an endoscopic biliary drainage (EBD) stent, the proximal tip of the device was found to have migrated into the abdominal cavity. Cannulation of the gallbladder was performed, and an attempt was made to retrieve the device using grasping forceps. However, significant resistance was encountered when the proximal tip migrated into the stomach, and the procedure was discontinued. A subsequent retrieval attempt was made using a snare; however, the snare broke during the procedure. Retrieval was then reattempted using grasping forceps. Repeated attempts with the forceps resulted in separation of the device. The separated and unraveled device components were subsequently retrieved piece by piece until the entire device had been removed. The end

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086728 ↗
• MalfunctionJul 15, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE STOMACH TO TREAT ACUTE PANCREATITIS DURING AN ENDOSCOPY ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE HANDLE BROKE DURING STEP 2 PREVENTING THE STENT FROM BEING FULLY RELEASED. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DEVICE FROM THE PANCREATIC CYST AND ANOTHER OF THE SAME 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 25830679 ↗
• DeathJun 5, 2026Adverse 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 transduodenally to the gallbladder for the treatment of acute cholecystitis during a pancreatic cystic gastric (intestinal) bypass procedure performed on (b)(6) 2025. The AXIOS stent was successfully implanted, and no device-related problems were identified at that time.On (b)(6) 2025, approximately 10 days following the procedure, no improvement in the patient's clinical condition was reported. The patient developed peritonitis and a decrease in albumin level to 1.6 was noted. These events were managed with unspecified conservative treatment. The relationship between the reported peritonitis and the AXIOS stent could not be determined. According to the available information, the patient's general condition had already been poor prior to the procedure and multiple comorbidities were present. The patient subsequently expired, and the reported cause of death was peritonitis.

  Patient problems: Blood Protein Abnormal; Peritonitis

  MAUDE report 25409730 ↗
• MalfunctionMay 12, 2026Positioning Problem; Activation 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 TREAT PANCREATIC PSEUDOCYST DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE FIRST FLANGE OF THE STENT DID NOT FULLY EXPAND. ADDITIONALLY, THE PHYSICIAN DECIDED TO FULLY DEPLOY THE STENT TO SEE IF IT WOULD FULLY EXPAND UPON DEPLOYING THE 2ND FLANGE BUT THE STENT BECAME DISLODGED FROM ITS TARGETED DEPLOYMENT IMMEDIATELY DUE TO THE DISTAL (INITIAL) FLANGE NOT BEING FULLY EXPANDED. THE PHYSICIAN TOGGLED THE CATHETER BACK AND FORTH IN AN ATTEMPT TO GET THE STENT TO OPEN FULLY. EVENTUALLY, THE STENT WAS PULLED OUT AND THEN DEPLOYED ANOTHER OF THE SAME DEVICE 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 25152977 ↗
• MalfunctionMay 11, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SECOND PORTION OF THE STENT WOULD NOT DEPLOY. ADDITIONALLY, IT WAS REPORTED THAT THE FIRST PORTION DID DEPLOY. THE PHYSICIAN HAD TO REMOVE THE STENT AND REDEPLOY ANOTHER AXIOS STENT OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145258 ↗
• MalfunctionMay 11, 2026Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT PANCREATIC FLUID COLLECTION (PFC) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER INPUTTING THE CATHETER INTO THE PSEUDOCYST, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST FLANGE, BUT THE GREY HUB BROKE OFF THE CATHETER. THEREFORE, THE PHYSICIAN PLACED THE WIRE DOWN THE CATHETER TO HOLD THE POSITION AND REMOVED IT. THE PROCEDURE WAS ABLE TO BE COMPLETED BY ANOTHER OF THE SAME DEVICE OVER THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144876 ↗
• 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 TRANSDUODENAL TO TREAT PANCREATIC PSEUDOCYST DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT DISTAL FLANGE DID NOT DEPLOY. 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 25144868 ↗
• 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 IN THE STOMACH TO GATHER A FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT WAS UNABLE TO DEPLOY. IN ORDER TO FACILITATE THE RELEASE, THE PHYSICIAN TRIED TO REDEPLOY IT BUT DID NOT WORK. THE HANDLE BROKE SO THE PHYSICIAN HAD TO REMOVE THE DEVICE. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144866 ↗
• 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 IN THE AREA TO PERFORM AN AXIOS PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE STENT. ALTHOUGH THE DOCTOR ATTEMPTED DEPLOYMENT, THE STENT DID NOT RELEASE, AND NO DEPLOYMENT WAS VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144414 ↗
• MalfunctionMay 11, 2026Break; Positioning 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 TRANSGASTRIC TO PANCREAS TO TREAT WALL-OFF NECROSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GREY HUB FAILED TO DEPLOY THE DISTAL FLANGE. THE HUB FLOATED LOOSELY AND WAS NOT ABLE TO DEPLOY THE STENT. THE STENT WAS RETRIEVED FULLY COVERED BY THE 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 25144408 ↗
• MalfunctionMay 11, 2026Positioning Failure; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PROPERLY PERFORM THE INITIAL STEP TO TENT THE TISSUE DUE TO DIFFICULTY ATTACHING THE HANDLE TO THE EUS SCOPE USING THE LUER LOCK. THE STENT WAS NOT DEPLOYED, AND IT WAS RETRIEVED FULLY COVERED BY THE OUTER SHEATH. 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 25144407 ↗
• MalfunctionMay 11, 2026Positioning Failure

  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 WALLED-OFF NECROSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT FAILED TO BE DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144405 ↗
• MalfunctionMay 11, 2026Positioning Failure; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE TRANSGASTRIC TO PANCREAS AREA TO PERFORM AN EUS PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY EXTENDING THE CATHETER AND DEPLOYING THE STENT. THE DEVICE WAS PREPARED ACCORDINGLY AND PASSED THROUGH THE SCOPE. WHEN THE BOTTOM LOCK WAS UNLOCKED AND THE PHYSICIAN ATTEMPTED TO EXTEND THE CATHETER, IT APPEARED TO CATCH AND DID NOT EXTEND SMOOTHLY. MORE FORCE WAS REQUIRED TO INCREMENTALLY EXTEND THE CATHETER. THE DEVICE WAS REMOVED FROM THE SCOPE, AND THE CATHETER WAS TESTED AGAIN, BUT THE SAME ISSUE PERSISTED. THE DEVICE WAS THEN RETRIEVED, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER AXIOS STENT OF DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144399 ↗
• 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 TRANSGASTRIC TO PANCREAS FOR THE TREATMENT OF WALLED-OFF NECROSIS DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE FIRST FLANGE OF THE AXIOS STENT. THE PHYSICIAN REMOVED THE STENT UNDEPLOYED FROM THE CATHETER AND A SECOND AXIOS STENT WAS THEN INSERTED THROUGH THE PREVIOUSLY CREATED PUNCTURE TRACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144380 ↗
• 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 IN THE STOMACH TO TREAT A PANCREATIC CYST PPC DURING A PANCREATIC CYST GASTRIC BYPASS PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE AXIOS STENT DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND ANOTHER AXIOS 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 25144321 ↗
• MalfunctionApr 23, 2026Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED INTO THE PANCREAS FOR DRAINAGE OF AN APPROXIMATELY 8 CM PANCREATIC PSEUDOCYST WITH AN ESTIMATED WALL THICKNESS OF 3-4 MM DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE INITIAL PUNCTURE WAS SUCCESSFULLY ACHIEVED, AND THE FIRST FLANGE DEPLOYED AS INTENDED. HOWEVER, DIFFICULTY WAS ENCOUNTERED DURING DEPLOYMENT OF THE DISTAL FLANGE. RESISTANCE WAS ALSO EXPERIENCED DURING WITHDRAWAL OF THE CATHETER FROM THE ENDOSCOPE. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED FOLLOWING THE PROCEDURE DID NOT DEMONSTRATE THE PRESENCE OF A STENT, INDICATING THAT THE STENT WAS NOT DEPLOYED. AS NO AXIOS STENT WAS AVAILABLE FOR REPLACEMENT, THE PROCEDURE COULD NOT BE COMPLETED AS INTENDED, AND THE PUNCTURE SITE WAS LEFT OPENED. A SMALL AMOUNT OF DRAINAGE WAS ACHIEVED, AND THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMATIC IMPROVEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967557 ↗
• MalfunctionApr 8, 2026Difficult to Remove; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE BILE DUCTS TO TREAT A BILIARY OBSTRUCTION TROUGH DURING A GALLBLADDER DRAINAGE DURING ENDOSCOPIC ULTRASOUND PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AXIOS SUCCESSFULLY DEPLOYED BUT AS THE INNER CATHETER WAS BEING TAKEN OUT THE NOSE CONE OF THE DELIVERY SYSTEM, IT GOT HOOKED ON THE SADDLE OF THE STENT AND WAS NOT ABLE TO BE REMOVED. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN OUT THE SCOPE AND GET INTO A BETTER POSITION IN ORDER TO WITHDRAW BUT IT WOULD NOT COME OUT OF THE STENT SO THE PHYSICIAN TRIED TO RESHEATHED THE DELIVERY SYSTEM AND ADVANCED THE CATHETER BACK THROUGH THE STENT WHICH COVERED THE NOSE CONE IN ORDER TO BE REMOVED. AT THE END, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE PHYSICIAN RESHEATHED THE STENT BY TRYING TO REVERSE THE HANDLE BACK TO STEP ONE. HOWEVER, PER THE INSTRUCTION FOR USE (IFU) "THE STENT CANNOT BE RESHEATHED AFTER THE STENT FIRST FLANGE HAS BEEN DEPLOYED." THEREFORE, THE INSTRUCTION FOR USE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817780 ↗
• InjuryMar 17, 2026Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE GALLBLADDER TO TREAT CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM, RESISTANCE WAS ENCOUNTERED, AND THE CONE OF THE CAUTERY TIP BECAME CAUGHT ON THE DISTAL FLANGE. SUBSEQUENTLY, THE INNER SHEATH AND TIP DETACHED AND WERE REMOVED USING RESCUE FORCEPS. DESPITE THE 15 MINUTES DELAY, THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWED THAT THE INNER SHEATH WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618795 ↗
• InjuryMar 11, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED BETWEEN THE GASTRIC SIDE AND GALLBLADDER SIDE TO TREAT CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND INITIAL STENT PLACEMENT APPEARED NORMAL. A FEW DAYS LATER, CT IMAGING CONFIRMED THE STENT WAS IN GOOD POSITION. HOWEVER, SHORTLY THEREAFTER THE PATIENT DEVELOPED ACUTE SEPSIS. FOLLOW-UP CT REVEALED THAT THE STENT HAD MIGRATED, DISLODGING FROM BOTH THE GASTRIC AND GALLBLADDER SIDES, AND WAS FREE-FLOATING WITHIN THE PERITONEAL CAVITY. PLANS WERE MADE TO PLACE A PERCUTANEOUS DRAIN, AS THE PHYSICIAN NOTED THE PATIENT WAS QUITE SICK. IT WAS REPORTED THE PATIENT DEVELOPED ACUTE SEPSIS AND NOTED THE PATIENT WAS QUITE SICK.

  Patient problems: Sepsis

  MAUDE report 24568160 ↗
• MalfunctionMar 3, 2026Positioning 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 PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) CYST GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. 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 SECOND FLANGE WAS DEPLOYED WITHIN THE WORKING CHANNEL OF THE ENDOSCOPE. THE DELIVERY SYSTEM HANDLE WAS THEN USED TO ADVANCE AND RELEASE THE FLANGE FROM THE WORKING CHANNEL; HOWEVER, DURING ACTUATION OF THE HANDLE, THE AXIOS STENT FULLY DEPLOYED INTO THE FLUID COLLECTION. UNDER ULTRASOUND VISUALIZATION, THE STENT WAS OBSERVED TO BE FULLY EXPANDED. A NON-BOSTON SCIENTIFIC STENT WAS SUBSEQUENTLY PLACED TO MAINTAIN LUMINAL PATENCY FOR DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503327 ↗