Axios™ M00553740Recalls & reported problems
Boston Scientific Corporation · Stent and Delivery System · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729904625), received between Jan 9, 2020 and Apr 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (1 report).
1 FDA recall record 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.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Activation Failure1
- Activation, Positioning or Separation Problem1
- Break1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2024Break; Activation, Positioning or Separation Problem; Break; 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 TRANSGASTRIC TO THE PANCREAS DURING A TRANSGASTRIC FLUID COLLECTION DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED BUT THEN THE HANDLE BROKE. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034437 ↗InjuryJan 9, 2020Use of Device Problem; Activation Failure; Use of Device Problem; Activation Failure
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS FULLY DEPLOYED, THE STENT FAILED TO EXPAND. HE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND A SECOND HOT AXIOS STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE HOT AXIOS STENT WAS BEING IMPLANTED IN THE ESOPHAGUS; HOWEVER, THE HOT AXIOS STENT AND DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6CM IN SIZE AND WALLED-OFF NECROSIS >= 6CM IN SIZE WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9572309 ↗
Other pancreatic stent, covered, metallic, removable devices
- Axios™ M00553660Boston Scientific Corporation · pancreatic stent, covered, metallic, removable3 recalls7 deaths301 reports
- Axios™ M00553650Boston Scientific Corporation · pancreatic stent, covered, metallic, removable2 recalls5 deaths338 reports
- Axios™ M00553640Boston Scientific Corporation · pancreatic stent, covered, metallic, removable2 recalls2 deaths142 reports
- Axios™ M00553680Boston Scientific Corporation · Pancreatic stent, covered, metallic, removable2 recalls20 reports
- Axios™ M00553690Boston Scientific Corporation · Pancreatic stent, covered, metallic, removable2 recalls13 reports
- Axios™ M00553670Boston Scientific Corporation · Pancreatic stent, covered, metallic, removable1 recall25 reports
- Axios™ M00553750Boston Scientific Corporation · pancreatic stent, covered, metallic, removable1 recall19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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