HEADWAY MC17215045X-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429117446), received between Feb 19, 2026 and Mar 31, 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.

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.

• MalfunctionMar 31, 2026Material Protrusion/Extrusion

  AS REPORTED, IMPOSSIBLE TO INTRODUCE THE WEB IN 3 MICROCATHETERS: (X2) VIA 17 AND (X1) HEADWAY 17, LOT: 000993008. THE PHYSICIAN FINALLY DECIDED TO USE AN ARTISSE. THERE WAS NO REPORT OF INJURY. NO CONSEQUENCE FOR THE PATIENT. WHEN THE DEVICE, HEADWAY 17 MICROCATHETER WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS REVEALED AN EXPOSED LUMEN COIL PROTRUDING INTO THE CATHETER LUMEN. THEREFORE, A REPORT IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748663 ↗
• MalfunctionFeb 19, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER. THE MICROCATHETER AND COIL WERE BOTH REMOVED FROM THE PATIENT WITHOUT ANY ADVERSE EVENTS. THERE WAS NO PATIENT INJURY. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND THE LUMEN TO NOT BE FULLY FLARED AT THE HUB JOINT WITH EXPOSED BRAID IN THE LUMEN, AND DELAMINATED PTFE WAS IN THE LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396990 ↗