TRUFILL DCS ORBIT 637HF0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704029663), received between Mar 3, 2017 and Mar 3, 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.

• MalfunctionMar 3, 2017Stretched; Stretched

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL THAT DURING COIL EMBOLIZATION AT THE ANTERIOR COMMUNICATING ARTERY RESISTANCE WAS EXPERIENCED WHEN USING AN ORBIT HELICAL 2 X 4 COIL AND THE COIL WAS FOUND TO BE STRETCHED. THE COIL COULD NOT BE INSERTED INTO THE HUB OF THE MICROCATHETER; THE COIL WAS WITHDRAWN FROM THE MICROCATHETER AND WAS FOUND TO BE STRETCHED. THE COMPLAINT COIL WAS REMOVED FROM THE MICROCATHETER STILL ATTACHED TO THE DELIVERY SYSTEM, THE REPORTED EVENT DID NOT REQUIRE REMOVAL OF THE CATHETER. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. PRIOR TO THE COMPLAINT COIL OTHER COILS WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COIL PRIOR TO USE. THERE WAS NO REPORT ON THE PATIENT INJURY. IT WAS INITIALLY REPORTED THAT THE COMPLAINT COIL IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6376157 ↗