TRUFILL DCS ORBIT 637MF3575Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704029953), received between Oct 17, 2016 and Oct 17, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance” (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.

• MalfunctionOct 17, 2016Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THERE WAS RESISTANCE WHEN THE ORBIT MINI COMPLEX FILL COIL (637MF3575/ 17271359) WAS BEING ADVANCED THROUGH THE UNSPECIFIED MICROCATHETER, AND THE COIL STRETCHED. THE COIL HAD NOT EXITED THE MICROCATHETER. THEY WITHDREW THE ENTIRE COIL STILL ATTACHED TO THE DELIVERY SYSTEM FROM THE MICROCATHETER, AND USED A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER, AND THERE WERE NO KINKS IN THE MICROCATHETER. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6033421 ↗