AxiosRecalls & reported problems across all models

We found 8 models of Axios by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 860 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Sep 24, 2026 — classified as 14 deaths, 424 injuries, 422 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (270 reports).

14 FDA recall records name at least one of these models by its device identifier, 11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Axios recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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-1159-2026 · Root cause: Process control · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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-1031-2025 · Root cause: Process control · Recall details · FDA record ↗

5. 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-1030-2025 · Root cause: Process control · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. 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-1028-2025 · Root cause: Process control · Recall details · FDA record ↗

8. 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-1027-2025 · Root cause: Process control · Recall details · FDA record ↗

9. 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 · Recall details · FDA record ↗

10. 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 · Recall details · FDA record ↗

11. 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 · Recall details · FDA record ↗

12. 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 · Recall details · FDA record ↗

13. 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 · Recall details · FDA record ↗

14. 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 · Recall details · FDA record ↗

Most reported Axios problems

Axios models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Axios™ M00553660

  pancreatic stent, covered, metallic, removable
  3 recalls7 deaths301 reports
• Axios™ M00553650

  pancreatic stent, covered, metallic, removable
  2 recalls5 deaths338 reports
• Axios™ M00553640

  pancreatic stent, covered, metallic, removable
  2 recalls2 deaths142 reports
• Axios™ M00553680

  Pancreatic stent, covered, metallic, removable
  2 recalls20 reports
• Axios™ M00553690

  Pancreatic stent, covered, metallic, removable
  2 recalls13 reports
• Axios™ M00553670

  Pancreatic stent, covered, metallic, removable
  1 recall25 reports
• Axios™ M00553750

  pancreatic stent, covered, metallic, removable
  1 recall19 reports
• Axios™ M00553740

  pancreatic stent, covered, metallic, removable
  1 recall2 reports

Recent Axios adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 17, 2026Positioning Failure; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278459 ↗
• 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 ↗
• 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 25, 2026Entrapment of Device

  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 DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SECOND FLANGE DID NOT DEPLOY OUT OF THE SCOPE. THE PHYSICIAN TRIED TO PLUNGE AND TORQUE SCOPE TO THE RIGHT BUT WAS UNSUCCESSFULLY. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY USING ANOTHER AXIOS STENT THROUGH THE INITIAL PUNCTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630305 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports