Headway Advanced Soft MC172150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170013744), received between Nov 7, 2025 and Aug 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455682 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: PATIENT WAS TO BE TREATED FOR A RUPTURED ACOM ANEURYSM WITH STENT ASSISTED COILING. HEADWAY 17 WAS PARKED ACROSS THE ACOM IN THE SAC. THE FIRST COIL SELECTED DEPLOYED IN THE SAC WITHOUT DETACHING IT. STENT WAS SELECTED, PREPARED AS PER THE IFU AND INTRODUCED INTO THE MICROCATHETER HUB. WHILE TRANSFERRING THE STENT TO THE MICROCATHETER, THE PHYSICIAN FELT RESISTANCE, BUT WHEN HE SAW THAT STENT WAS GOING INSIDE THE CATHETER, HE CONTINUED PUSHING IT. BUT AFTER A COUPLE OF MM, THE STENT GOT STUCK AND WAS NOT MOVING TO AND FRO. PHYSICIAN DID APPLY A LOT OF PRESSURE AND MANEUVERS, BUT THE STENT DID NOT MOVE. DURING THESE MANEUVERS, THE INTRODUCER SHEATH JUMPED BACKWARD AND THE STENT GOT COMPLETELY EXPOSED IN THE MICROCATHETER HUB. LOOKING AT THIS, PHYSICIAN TOOK OUT THE COMPLETE ASSEMBLY, INCLUDING HEADWAY 17 AND STENT, AND KEPT IT ASIDE. COMPLETED THE CASE WITH A NEW HEADWAY 17 AND STENT. PATIENT WAS EXTUBATED & DISCHARGED AFTER FIVE DAYS. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED LUMEN COIL PROTRUDING INTO THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504020 ↗