Axios™ M00553660Recalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 08714729951179), received between Sep 6, 2018 and Sep 24, 2026 — classified as 7 deaths, 130 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (142 reports).

3 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-1158-2026 · 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-1026-2025 · Root cause: Process control · FDA record ↗

3. 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-0775-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Positioning Problem

  Boston Scientific became aware of an event involving an Axios Stent and Electrocautery Enhanced Delivery System through the article "Retrieving a mis deployed lumen-apposing metal stent using a large-channel scope" by Mark Kowalczyk, et al.Per the article, a 72-year-old woman with recent necrotizing gallstone pancreatitis presented to the hospital with worsening abdominal pain. Computed tomography showed a 120 x 80-mm walled-off necrosis adjacent to the body of the pancreas. The stent was intended to be implanted transgastrically to the pancreas. During the procedure, following deployment, the stent was noted to have been deployed entirely within the pancreatic fluid collection. A second 20 x 10 mm LAMS was subsequently deployed at a new site under endoscopic and fluoroscopic guidance, and the stent was dilated to 15 mm. The initial puncture site was not closed, as the fluid collection was adherent to the gastric wall and spontaneous closure was anticipated without adverse outcomes. The misplaced stent was visualized within the collection, grasped with a snare, and successfully removed through the endoscope. Two double-pigtail stents were then placed between the gastric lumen and p

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885482 ↗
• MalfunctionMay 12, 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 TRANSGASTRIC TO PANCREAS TO TREAT WALLED-OFF NECROSIS DURING AN EUS (ENDOSCOPIC ULTRASOUND) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS NOT ABLE TO BE DEPLOYED. THE STENT WAS RETRIEVED FULLY COVERED BY THE OUTER SHEATH AND 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 25150114 ↗
• 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 TREAT WALLED OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS 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 25145254 ↗
• 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 GASTRIC AREA TO FACILITATE FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. IN ORDER TO FACILITATE RELEASE THE PHYSICIAN ATTEMPTED TO RE DEPLOY, BUT IT WAS UNSUCCESSFULLY. 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 25145252 ↗
• 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 DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE HANDLE BROKE INTO SEVERAL PLACES, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145183 ↗
• MalfunctionMay 11, 2026Break; Positioning 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 LOWER ESOPHAGEAL SPHINCTER (LES) AREA TO PERFORM AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PYLORIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AXIOS CATHETER WAS PASSED THROUGH THERAPEUTIC UPPER SCOPE, DURING STEP 2 THE GREY HUB BROKE IN HALF AND FELL OFF THE DEPLOYMENT HANDLE. THE PHYSICIAN ATTEMPTED TO REATTACH THE GRAY HUB, BUT IT WOULD NOT DEPLOY THE FIRST FLANGE OF THE DEVICE. 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 AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM WAS USED TO TREAT A PYLORIC STENOSIS. PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE (DFU), 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 STENT IS NOT INDICATED FOR A PYLORIC STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144895 ↗
• MalfunctionMay 11, 2026Positioning Failure; 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 TRANSGASTRIC TO TREAT WALLED OFF NECROSIS (WON) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY. IT WAS ALSO REPORTED THAT SQUEEZING THE HANDLE WAS DIFFICULT AND THAT THE HANDLE BECAME JAMMED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE FIRST STENT AND INSERT ANOTHER OF THE SAME TYPE; HOWEVER, THE SAME ISSUE WAS REPORTED WITH THIS SECOND STENT (SUBJECT OF THIS REPORT). THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME DEVICE (THIRD STENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144890 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS AREA TO PERFORM AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT. THEY INITIALLY PLACED, AXIOS FOR PANCREATIC PSEUDOCYST WAS REMOVED AFTER THE DISTAL FLANGE COULD NOT BE DEPLOYED DESPITE MULTIPLE ATTEMPTS. THE SCOPE WAS STRAIGHTENED AND ANOTHER AXIOS STENT WAS INSERTED; HOWEVER, THE SAME ISSUE OCCURRED (SUBJECT OF THIS REPORT). THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY WITH A DIFFERENT AXIOS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144888 ↗
• 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 TRANSGASTRIC TO PANCREAS DURING AN (EUS) ENDOSCOPIC ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BECAME STRIPPED AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED WITH 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 25144887 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSGATSRIC TO THE PANCREAS AREA TO PERFORM AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT. THEY INITIALLY PLACED, AXIOS FOR PANCREATIC PSEUDOCYST WAS REMOVED AFTER THE DISTAL FLANGE COULD NOT BE DEPLOYED DESPITE MULTIPLE ATTEMPTS (SUBJECT OF THIS REPORT). THE SCOPE WAS STRAIGHTENED AND ANOTHER AXIOS STENT WAS INSERTED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY WITH A DIFFERENT AXIOS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144886 ↗
• 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 FACILITATE A PSEUDOCYST DRAINAGE DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, 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 PHYSICIAN REPORTED THAT THE STENT DID NOT 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 25144885 ↗
• MalfunctionMay 11, 2026Positioning Failure; 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 TRANSGASTRIC TO TREAT WALLED OFF NECROSIS (WON) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY. IT WAS ALSO REPORTED THAT SQUEEZING THE HANDLE WAS DIFFICULT AND THAT THE HANDLE BECAME JAMMED (SUBJECT OF THIS REPORT). THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE FIRST STENT AND INSERT ANOTHER OF THE SAME TYPE; HOWEVER, THE SAME ISSUE WAS REPORTED WITH THIS SECOND STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME DEVICE (THIRD STENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144877 ↗
• 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT HAD PRE-EXISTING COMORBIDITIES, INCLUDING PNEUMONIA AND MORBID OBESITY. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT FAILED TO DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144875 ↗
• 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 TREAT PSEUDOCYST DURING A GI (GASTROINTESTINAL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT SNAPPED AND BROKE WHILE ATTEMPTING 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 25144873 ↗
• 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 A CYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS STENT FIRST FLANGE DID NOT DEPLOY. 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 25144872 ↗
• 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 TREAT A PSEUDOCYST DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE FLANGE WOULD NOT OPEN WHEN ATTEMPTING TO DEPLOY. ADDITIONALLY, THE PHYSICIAN TRIED MULTIPLE TIMES TO DEPLOY STENT BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY REPLACING AND 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 25144869 ↗
• MalfunctionMay 11, 2026Break; Positioning 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 TRANSGASTRIC TO TREAT PSUEDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE AXIOS STENT GRAY DEPLOYMENT HUB SNAPPED WHEN TRYING TO DEPLOY THE FIRST FLANGE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY REMOVING THE OLD STENT AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER, THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "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 INSTRUCTION FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144859 ↗
• MalfunctionMay 11, 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 STOMACH AREA TO PERFORM AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN HAD A PROBLEM WITH DEPLOYING THE STENT; THE DISTAL FLANGE DID NOT DEPLOY. 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 IMPLANTED IN THE STOMACH TO TREAT AN ANASTOMOTIC STRICTURE DURING AN EGD PROCEDURE. 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 AND WALLED-OFF NECROSIS 6 CM IN SIZE WITH 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE STENT IS NOT INDICATED TO BE PLACED TO TREAT AN ANASTOMOTIC STRICTURE IN THE STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144858 ↗
• MalfunctionMay 11, 2026Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT WITH ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED FOR TRANSGASTRIC IMPLANTATION TO TREAT CHRONIC PANCREATITIS SECONDARY TO A PANCREATIC CYST DURING AN UPPER GASTROINTESTINAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE AXIOS FIRST FLANGE WOULD NOT DEPLOY. AFTER MULTIPLE TRIES WITH TROUBLESHOOTING TECHNIQUES THE PRODUCT WAS REMOVED. 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 HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144857 ↗
• 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 TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AT STEP 2 OF THE DEPLOYMENT, A SNAPPING SOUND WAS NOTED INSIDE THE AXIOS CATHETER. SUBSEQUENT ATTEMPTS TO DEPLOY THE STENT WERE UNSUCCESSFUL, AS IT DID NOT EXIT THE CATHETER. THE PHYSICIAN TRIED TO MOVE THE CATHETER CONTROL HUB UP AND DOWN SEVERAL TIMES IN AN EFFORT TO RELEASE THE STENT, BUT DEPLOYMENT COULD NOT BE ACHIEVED. A WIRE WAS IN PLACE, ALLOWING REMOVAL OF THE AXIOS CATHETER. A SECOND AXIOS CATHETER WAS THEN ADVANCED OVER THE WIRE 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 25144854 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE DUODENAL TO TREAT A STRICTURE DURING A STRICTURE MANAGEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE AXIOS STENT DID NOT DEPLOY. ADDITIONALLY, THE PHYSICIAN TRIED MULTIPLE TECHNIQUES BUT DID NOT WORK. IT WAS NOTED THAT THE CATHETER BENT AND BROKE DURING THE EVENT. 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. IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED IN THE DUODENAL/PYLORIC AREA TO TREAT STRICTURE. 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 PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144853 ↗
• 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 DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. 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 25144409 ↗
• MalfunctionMay 11, 2026Break; Positioning Failure; 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 TO BE IMPLANTED IN THE PYLORUS AREA TO TREAT A PYLORIC STRICTURE DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE STENT. DURING THE FIRST FLANGE DEPLOYMENT, THE PULL HANDLE BROKE, AND THE SHEATH COULD NO LONGER BE ADVANCED. THE DEVICE WAS RETRIEVED AND THE STENT WAS MANUALLY DEPLOYED OUTSIDE THE PATIENT BY MANIPULATING THE SHEATH TO RELEASE IT, RELOADED INTO THE TIP OF THE SCOPE, AND SUBSEQUENTLY DEPLOYED USING RESCUE FORCEPS. NOTE: IT WAS REPORTED THAT THE STENT WAS MANUALLY DEPLOYED OUTSIDE THE PATIENT BY MANIPULATING THE SHEATH TO RELEASE IT, RELOADED INTO THE TIP OF THE SCOPE, AND SUBSEQUENTLY DEPLOYED USING RESCUE FORCEPS. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTIONS FOR USE (IFU). NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS TO BE IMPLANTED TO TREAT A PYLORIC STRICTURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144406 ↗
• MalfunctionMay 11, 2026Positioning Failure

  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 A PANCREATIC PSEUDOCYST DURING A DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS NOT ABLE TO BE DEPLOYED. THE FIRST STEP OF THE DEPLOYMENT PROCESS WAS UNACHIEVED. THE DEVICE WAS RETRIEVED WITH THE STENT 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 25144402 ↗
• 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 TRANSGASTRIC TO THE CYST AREA TO PERFORM A PSEUDOCYST DRAINAGE PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT DEPLOY THE STENT AT THE FIRST FLANGE, THE STENT STAYED COMPLETELY COVERED IN THE CATHETER. 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 25144384 ↗