TRUFILL DCS ORBIT 638CF0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704029991), received between Jan 20, 2017 and Mar 27, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2019Premature Activation; Stretched; Material Twisted/Bent; Premature Activation; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF 8.2 MM X 6.8 MM IRREGULAR ANEURYSM ON THE LEFT ANTERIOR COMMUNICATING ARTERY, THE 5 MM X 15 CM TRUFILL ORBIT COMPLEX FILL COIL (638CF0515 / 30003280) WAS SELECTED FOR THE DENSE EMBOLIZATION PROCEDURE. THE PRODUCT WAS CHECKED AND FOUND TO BE NORMAL BEFORE IT WAS USE. THE PHYSICIAN REPORTED THAT THE COIL COULD NOT ADVANCE FURTHER WHEN IT PASSED 1/3 OF THE TARGET LESION. THE COIL WAS REMOVED AND FOUND TO BE STRETCHED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT COIL THAT IS THE SAME AS THE ORBIT COMPLEX FILL COIL. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN THE LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457399 ↗
• MalfunctionOct 1, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN INTRACRANIAL ANEURYSM, THE TRUFILL DCS ORBIT COMPLEX FILL 5MM X 15CM COIL (638CF0515 / 17710998) BECAME STRETCHED DURING INSERTION THROUGH THE MICROCATHETER (UNKNOWN BRAND). RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER WAS NOT REPORTED. IT WAS CONFIRMED THAT THERE WAS NO KINK ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. ANY RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER DURING THE ACCESS OF THE TARGET SITE WAS NOT REPORTED. THE ENTIRE TRUFILL DCS ORBIT COMPLEX FILL COIL WAS WITHDRAWN AND REMOVED UNDETACHED AND WITHOUT ANY ADDITIONAL DAMAGE; IT WAS REPLACED WITH ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO FLOW REDUCTION OR RESTRICTION ASSOCIATED WITH THE REPORTED ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922849 ↗
• MalfunctionJun 27, 2017Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THE ORBIT COMPLEX FILL COIL (638CF0515/17558529) COULD NOT SHAPE AS EXPECTED. THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. AN UNSPECIFIED SYRINGE WAS USED FOR THE PROCEDURE, AND THIS WAS THE FIRST COIL TO BE DETACHED. PRIOR TO ATTEMPT TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SAME SYRINGE WAS USED SUCCESSFULLY TO DEPLOY SUBSEQUENT COILS. NEITHER THE COIL NOR DELIVERY SYSTEM APPEARED DAMAGED DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6669409 ↗
• MalfunctionJan 24, 2017Stretched; Device Operates Differently Than Expected; Device Operational Issue; Stretched; Device Operates Differently Than Expected; Device Operational Issue

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN ORBIT COMPLEX FILL COIL (638CF0515/17072526) WAS USED DURING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM THAT WAS 4.8 X 4.1 MM IN SIZE; HOWEVER, THE FIRST COIL COULD NOT BE SHAPED AS EXPECTED AND WAS STRETCHED WHILE POSITIONING THE COIL. THE PHYSICIAN WITHDREW THE COIL WITH THE PROWLER 14 MICROCATHETER AND USED A NEW COIL TO COMPLETE THE PROCEDURE. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF PATIENT INJURY AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6273947 ↗
• MalfunctionJan 20, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE THE FIRST COIL USED AN ORBIT COMPLEX FILL COIL (638CF0515/17072526) COULD NOT BE SHAPED AS EXPECTED AND WAS STRETCHED. THE STRETCHING WAS NOTED DURING THE PLACEMENT OF THE COIL. THE COIL WAS WITHDRAWN ALONG WITH THE PROWLER 14 MICROCATHETER (CATALOG# /LOT UNKNOWN) AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO RESISTANCE EXPERIENCED WITH THE MICROCATHETER WHEN THE COIL WAS BEING ADVANCED OR WHEN WITHDRAWN THROUGH THE CATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR OLD MALE AND THE TARGET ANEURYSM WAS A SIZE OF 4.2*3.6 MM. THERE WAS NO REPORT ON PATIENT INJURY AND PATIENT OUTCOME WAS REPORTED TO BE FINE. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAYS RELATED TO DEVICE OR REPORTED EVENT. THERE WERE NO KINKS NOTED ON THE CATHETER AND NO DAMAGES NOTED ON THE CONCOMITANT DEVICES. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267544 ↗