MarksmanTM FA-55160-1030 (UDI 00847536008335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536008335), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2019Break; Collapse; Break; Collapse

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ATTEMPTED TO CROSS THE TARGET LESION WITH THE MARKSMAN CATHETER AND ARC INTRACRANIAL SUPPORT CATHETER, BUT THEY FAILED TO PASS IN SPITE OF REPEATED ATTEMPTS. THIS RESULTED IN A CRUSH/BREAK OF THE ARC, MARKSMAN DEVICES AT THE DISTAL END. THE PATIENT WAS UNDERGOING SURGERY OF AN ACUTE ISCHEMIC STROKE. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479885 ↗