Headway MC212156SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812636020945), received between Feb 13, 2025 and Nov 24, 2025 — classified as 1 injury, 1 malfunction.

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 16, 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.

• MalfunctionNov 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED: THE PHYSICIAN WAS TREATING A FUSIFORM ANEURYSM ON THE LEFT VERTEBRAL ARTERY. THE IMPLANTATION OF A SILK FLOWDIVERTER WAS PLANNED. A HEADWAY 21 WAS CHOSEN FOR THE PROCEDURE. IT WAS NOT POSSIBLE TO ADVANCE THE SILK (3,5-15) INTO THE HEADWAY 21. THE HEADWAY 21 WAS EXCHANGED AND THE SAME SILK WAS USED. THE EXAMINATION CONTINUED WITH GOOD RESULTS. THE PATIENT IS DOING WELL. NO INJURY CAUSED BY THIS ISSUE. NO OTHER INCIDENT INFORMATION WAS RECEIVED. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, THE INVESTIGATION FINDINGS FOUND AN EXPOSED LUMEN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636885 ↗
• InjuryFeb 13, 2025Material Protrusion/Extrusion; Unintended Movement; Material Protrusion/Extrusion; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. THE PLANNED TECHNIQUE WAS AN H-STENT CONSTRUCT WITH 2 FLOW DIVERTING STENTS. 1 FRED X GOING FROM RIGHT A2 ¿ A1 AND 1 X SILK VISTA BABY ON LEFT A2- A1. THE SILK VISTA BABY WAS ABLE TO BE IMPLANTED SUCCESSFULLY THROUGH A HEADWAY 17. DESPITE THE PATIENT ANATOMY BEING QUITE CHALLENGING AROUND THE ARCH, AND EVEN MORE CHALLENGING AROUND THE TARGETED SITE, THE PHYSICIAN CONTINUALLY EXPERIENCED EXCESSIVE FORCES AND COMPLAINED OF THE CONCERNED HEADWAY 21 MICROCATHETER CONTINUALLY SKIPPING. ACCESS TO THE TREATMENT SITE WAS QUITE TORTUOUS AND CHALLENGING AND THE PHYSICIAN WAS UNABLE TO RE-ACCESS THE LOCATION. THE PHYSICIAN ORIGINALLY DECIDED TO STOP THE PROCEDURE ON SAFETY GROUNDS AFTER ABOUT 4 HOURS, WITH THE INTENTION OF CHANGING TO SURGICAL APPROACH. SUBSEQUENTLY DECIDED TO TRY AN ENDOVASCULAR APPROACH AGAIN IN APPROXIMATELY 6 WEEKS TIME. THE PATIENT IS FINE AND THERE HAS BEEN NO CLINICAL SEQUELAE FROM THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379767 ↗