Headway Advanced MC17215090XRecalls & reported problems
Microvention, Inc. · Microcatheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170015489), received between Jul 10, 2025 and Feb 27, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE PROPERLY ADVANCED INTO THE CATHETER. BOTH DEVICES WERE RETRIEVED AND THE INVESTIGATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, IT WAS FOUND THAT THE CATHETER SHAFT EXHIBITED INCOMPLETE FLARING WITH EXPOSED BRAID AT THE HUB TRANSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477362 ↗MalfunctionJul 10, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS INITIALLY REPORTED, THE GUIDEWIRE WAS NOT ADVANCED IN THE HEADWAY 17 MICROCATHETER. THE PROCEDURE WAS COMPLETE WITH ANOTHER PRODUCT. THE PATIENT WAS REPORTED TO BE STABLE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE CATHETER EXHIBITED EXPOSED COIL IN THE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467986 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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