HEADWAY MC172150SX-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429117439), received between Apr 24, 2025 and Sep 23, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that when the microcatheter Headway-17 was opened the device was straight, but when the microguide was advanced by 0.014 mm, the doctor realized it wasn't progressing. He tried repeatedly, but it was never possible. The device was inspected and found to be fractured in the proximal portion. Another device is used to resolve the case. The patient is in good clinical condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872020 ↗
• MalfunctionDec 4, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDE WIRE DID NOT PASS SMOOTHLY THROUGH THE MICROCATHETER. A NEW CATHETER WAS USED TO COMPLETE THE CASE. THE PATIENT IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE POST EVALUATION REPORT REVEALED AN EXPOSED COIL AND DAMAGED/MISSING PTFE LINING AT THE HUB TRANSITION, WHICH WOULD HAVE CONTRIBUTED TO THE RESISTANCE ENCOUNTERED DURING THE INVESTIGATION. THE PTFE DAMAGE/DELAMINATION AND RESULTING OCCLUSION ARE CONSISTENT WITH ADVANCING ANOTHER DEVICE THROUGH THE MICROCATHETER WITH EXPOSED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717878 ↗
• InjuryApr 24, 2025Break; Break

  ADDITIONAL CLARIFYING INFORMATION RECEIVED NOTES THAT THE TYPE OF CASE PERFORMED WAS FOR A STENT COIL PROCEDURE. THE HEADWAY MICROCATHETER WAS PLACED WITHIN THE ANEURYSM, AND THE STENT WAS PLACED USING ANOTHER HEADWAY MICROCATHETER. AFTER COMPLETING THE COILING, THE DOCTOR TRIED TO REMOVE THE MICROCATHETER, BUT IT CAUGHT THE STENT CELL AND THE MICROCATHETER DISTAL TIP WAS TORN OFF. THE PROCEDURE WAS FINISHED WITH THE DISTAL TIP OF THE MICROCATHETER REMAINING IN THE PATIENT BODY. THERE IS NO PLAN TO ADDRESS PIECE REMAINING IN THE PATIENT AND WE WILL WATCH THE PROGRESS OF THE PATIENT. THE DEVICE IS CURRENTLY PENDING RECEIPT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21906174 ↗