TRUFILL DCS ORBIT 638MF0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704030171), received between Jun 5, 2017 and Jun 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 5, 2017Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AN ORBIT MINI COMP FILL 4X10 TDL (638MF0410/17526643) COULD NOT BE DETACHED. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND GREEN SYSTEM READY LIGHT HAD ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COIL WAS WITHDRAWN AND UPON REMOVAL COIL STRETCHING WAS NOTED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DETACHMENT BOX WAS USED WITH THE SUBSEQUENT COILS. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL AND AN ADEQUATE 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 6612201 ↗