MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00553680
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.H6: imdrf device code a150201 captures the reportable event of stent failure to deploy.H11: boston scientific is initiating a removal of certain sizes of the axios stent and electrocautery enhanced delivery system (6mm x 8mm, 8mm x 8mm and 20mm x 10mm) manufactured since march 1, 2025.This action is being taken due to increased reports of stent deployment and expansion issues with these configurations.These issues only occur at the time of stent delivery and are expected to be noticed by the physician.Patients who have been treated with a successfully implanted axios stent should continue to follow standard of care and are not affected by this issue.A letter was sent out to materials managers/health care professionals on 19-dec-2025 to immediately stop further distribution or use of any affected 6mm x 8mm, 8mm x 8mm and 20mm x 10mm axios stent and electrocautery enhanced delivery system.The letter indicates to remove these devices from inventory and segregate them in a secure location until they can be returned to boston scientific.Despite multiple efforts, bsc was unable to confirm the batch number for the axios stent and electrocautery enhanced delivery system used in this event.Based on the reported clinical observations associated with failure to deploy and the date bsc was informed of this event, bsc is conservatively associating this event with the recall in an abundance of caution.The referenced axios stent and electrocautery enhanced delivery system met all specifications prior to final approval for distributions/sale.
Event or Problem Description
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 facilitate a pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the distal flange did not open, it failed to deploy.The procedure was completed by replacing and using another of the same device.There were no patient complications reported as a result of this event.It was reported that the patient fully recovered.

• Brand Name: AXIOS?
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24058182
• Report Number: 3005099803-2026-00189
• Device Sequence Number: 10023150
• Product Code: KNS
• UDI-Device Identifier: 00191506008086
• UDI-Public: (01)00191506008086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553680
• Device Catalogue Number: M00553680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-12192025-004-
• Patient Sequence Number: 1
• Patient Sex: Unknown