HEADWAY MC172150JX-ALRecalls & reported problems
Microvention, Inc. · Headway Advanced · Class 2
All models of HEADWAY (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429117460), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).
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/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Material Protrusion/Extrusion
IT WAS INITIALLY REPORTED THAT THE MICROWIRE COULD NOT BE INSERTED INTO THE CATHETER HUB. A NEW HEADWAY PRODUCT WAS USED INSTEAD. THE PATIENT WAS REPORTED TO BE STABLE. WHEN THE DEVICE WAS RECEIVED AND ANALYZED, THE MICROCATHETER EXHIBITED AN EXPOSED COIL PROTRUDING INTO THE LUMEN AT THE HUB TRANSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228538 ↗
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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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