TRUFILL DCS ORBIT 637HF0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704029687), received between Jun 5, 2017 and Jul 15, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Stretched” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2019Migration or Expulsion of Device; Stretched; Detachment of Device or Device Component; Migration or Expulsion of Device; Stretched; Detachment of Device or Device Component

  AS REPORTED BY AN AFFILIATE, DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION PROCEDURE, AN 2X8 ORBIT HELICAL FILL COIL (637HF0208, 17760948) STRETCHED AND REMAINED IN V4 SEGMENT OF THE LEFT VERTEBRAL ARTERY, RESULTING IN CEREBRAL ISCHEMIC STROKE OF THE PATIENT. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT¿S CURRENT CONDITION IS STABLE. IT IS UNKNOWN IF SYMPTOMS RESOLVED OR IF THERE ARE RESIDUAL SYMPTOMS. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED BUT IT WAS REPORTED THAT FOLLOW UP INTERVENTION IS REQUIRED. THE STRETCHING OF THE COIL OCCURRED DURING POSITIONING/REPOSITIONING. THE COIL PROTRUDED INTO THE PARENT ARTERY. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THE UNKNOWN CONCOMITANT DEVICE(S) DID NOT FUNCTION AS EXPECTED. PROCEDURAL IMAGES ARE NOT AVAILABLE.

  Patient problems: Infarction, Cerebral; Obstruction/Occlusion

  MAUDE report 8789998 ↗
• MalfunctionJun 5, 2017Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THE ORBIT HELICAL FILL (637HF0208/ 17398602) COIL COULD NOT SHAPE AS EXPECTED (THE COIL WAS STRETCHED). THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE 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 6610633 ↗