Headway MC272156SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811425021385), received between Apr 2, 2019 and Sep 16, 2026 — classified as 1 injury, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793097 ↗
• MalfunctionApr 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THROMBECTOMY ON THE M2 SEGMENT OF THE LEFT MEDIAL ARTERY, THE CATHETER WAS TORN OFF AT THE PROXIMAL END DURING THE FIRST PASS. THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT¿S BODY COMPLETELY. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THE PATIENT WAS REPORTED TO BE ¿DOING WELL¿ AND THAT THIS EVENT CAUSED NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705432 ↗
• InjuryApr 2, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TREATMENT OF A CAVERNOUS OPHTHALMOPLEGIC ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY, A NON-MICROVENTION FLOW DIVERTER WAS DELIVERED THROUGH THE HEADWAY 27 MICROCATHETER AND IMPLANTED. TREATMENT WAS REPORTED TO BE SUCCESSFUL; HOWEVER, THE PATIENT'S CONDITION WORSENED AFTER 24 HOURS. AN MRI DEMONSTRATED GRANULOMAS AND COMPLETE OCCLUSION OF THE RIGHT HEMISPHERE. THE GRANULOMAS WERE SURGICALLY REMOVED FROM THE PATIENT AND ANALYSIS OF THE GRANULOMAS REVEALED PARTICLES OF PTFE. THE PATIENT WAS TRANSFERRED TO REHABILITATION. NO FURTHER INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT CONDITION.

  Patient problems: Embolism; Granuloma; Neurological Deficit/Dysfunction

  MAUDE report 8476448 ↗