HEADWAY MC162167S-ALRecalls & reported problems
Microvention, Inc. · Headway Duo · Class 2
All models of HEADWAY (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429117415), received between May 23, 2025 and Dec 18, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Fracture1
- Material Fragmentation1
- Material Protrusion/Extrusion1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Entrapment of Device; Fracture; Entrapment of Device; Fracture
IT WAS REPORTED THAT DURING A LEFT SIDE MMA EMBOLIZATION WITH LIQUID EMBOLIC, A HEADWAY DUO MICROCATHETER BECAME ENTRAPPED IN LIQUID EMBOLIC. THE PHYSICIAN LEFT A PORTION OF THE CATHETER IN THE EMBOLIC CAST AND REMOVED THE OTHER PORTION. THE PATIENT IS REPORTED TO BE DOING WELL AND IS STABLE.
Patient problems: Foreign Body In Patient
MAUDE report 23835946 ↗InjurySep 4, 2025Material Fragmentation; Material Fragmentation
AS REPORTED: OPERATOR BROKE CATHETER IN MMA BY LEAVING IT IN TOO LONG WITH THE LIQUID EMBOLIC. THE CATHETER WAS LEFT TOO LONG IN THE LIQUID EMBOLIC AND BECAME STUCK, SO WHEN THEY REMOVED IT THE CATHETER TIP BROKE OFF FORCEFULLY AND SOME WAS RETAINED IN THE LIQUID EMBOLIC. CASE WAS COMPLETED. PATIENT IS FINE.
Patient problems: Foreign Body In Patient
MAUDE report 22974260 ↗MalfunctionMay 23, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE MICROCATHETER HUB WAS FOUND TO BE DAMAGED DURING PREPARATION. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE LUMEN WAS FOUND TO HAVE NOT BEEN FULLY FLARED AT THE HUB JOINT, WITH AN EXPOSED BRAID AND DELAMINATED PTFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080860 ↗
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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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