TRUFILL DCS ORBIT 637MF3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704029946), received between Jun 1, 2017 and Jun 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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 18, 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.

• MalfunctionJun 1, 2017Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION PROCEDURE, AN ORBIT MINI COMPLEX FILL COIL (637MF3509/17222794) COULD NOT BE SHAPED AS EXPECTED. THE COIL COULD NOT BE PLACED INTO THE ANEURYSM AS EXPECTED, THE COIL WAS NOT CONFORMING TO THE WALLS OF THE ANEURYSM. THE COIL WAS WITHDRAWN AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. STRETCHING WAS NOTED ON THE COMPLAINT COIL; REPORTEDLY THE COMPLAINT COIL STRETCHED DURING PLACEMENT. THERE WERE NO DAMAGES NOTED ON THE CONCOMITANT DEVICES PRIOR TO USE OR UPON REMOVAL. THERE WAS NO REPORT ON THE PATIENT INJURY. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604712 ↗