TRUFILL DCS ORBIT 637MF2545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704029922), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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 2, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AN ORBIT MINI COMP FILL 2.5X4.5 (637MF2545/17326749) COULD NOT BE ADVANCED VIA MICROCATHETER. THE COIL WAS WITHDRAWN AND STRETCHING OF THE COIL WAS NOTED UPON REMOVAL, ONLY THE REPORTED COIL WAS REMOVED. A NEW COIL (CATALOG# 637MF2545) WAS USED WITH THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO REPORT OF PATIENT INJURY. THERE WAS NO DELAY OR INTERVENTIONAL TREATMENT DUE TO THE EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608494 ↗