Barricade Coil System 900106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053021053), received between Sep 10, 2018 and Feb 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Device Slipped; Stretched; Detachment of Device or Device Component; Device Slipped; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "THE CASE WAS AN ACOM ANUERYSM MEASURING 3MMX2.5MM AND HAVING A NECK OF 2.3 MM. SINCE IT WAS A RUPTURED ANUERYSM THE PHYSICIAN PLANNED TO DO A BALLOON ASSISTED COILING. THE SUPPORT HARDWARE WAS NEUROMAX ,FARGOMAX 6F, ECLISPE 6X9 ,VASCO 10 MP WITH HYBRID 12/14 GUIDE WIRE. THE FIRST COIL WAS COMPLEX FINISH 3MMX4MM. THE COIL WAS DEPLOYED WITH BALLOON INFLATION AND THE SECOND COIL WAS COMPLEX FINISH 2MMX3MM AND WHEN HALF A CM OF COIL WAS REMAINING TO BE PUSHED,THE MICRO WAS OUT OF THE ANUERYSM.THE PHYSCIAN WANTED TO WITHDRAW THE COIL IN ORDER TO REPOSITION THE MICRO WITH WIRE AND WHEN HE WAS ATTEMPTING TO WITHDRAW THE COIL IT HAD PREMATURELY DETACHED (NOTE:- NO MANUPILATION WAS DONE TO PUSH THE MICRO WITH THE COIL SUPPORT).NO MOVEMENT OF COIL WAS OBSERVED ON WITHDRAWL OF THE PUSH WIRE THE COIL HAD COME OUT HALF STRECHED ,THE PHYSCIAN USED THE HYBRID 12/14 THROUGH THE VASCO 10 TO ENSURE NO COIL WAS STILL PRESENT IN THE MICRO WITH THE ECLIPSE INFLATED BUT DURING THIS PROCESS SOME PART OF THE COIL CAME INTO THE ACA.THE MICRO AND BALLOON WAS REMOVED. THE PHYSCIAN USED XT 27 AND SOLITAIRE 4X20,CAPTURED THE COIL & REMOVED IT. POST REMOVAL OF THE STRECHED COIL ,THE PHYSC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334011 ↗
• MalfunctionSep 10, 2018Stretched; Unraveled Material; Stretched; Unraveled Material

  IT WAS REPORTED THAT: "THE SURGEON TRIED TO PLACE 2MM X 3CM COMPLEX FINISH COIL INTO THE AN BUT THE COIL HAS UNRAVELED DUE TO THE TIP OF SL-10 DROPPED OFF FROM THE AN. THEN UNRAVELED COIL(PRIMARY COIL) MOVED TO SIPHON REGION BY BLOOD FLOW. THEREFORE, A STENT (4.5 X 3 NEUROFORM ATLAS / STRYKER) WAS PLACED SIPHON REGION TO LOCK UNRAVELED COIL AND THE PUSHER WIRE WAS REMOVED, HOWEVER A PART OF COIL TAIL REMAINS WITHIN THE PATIENT. SURGEON'S COMMENTS: HE COMMENTED THAT THIS CASE MIGHT HAD BEEN OCCURRED DUE TO THE COIL CATCHING ON STRUT OF THE STENT. "

  Patient problems: Aneurysm; Patient Problem/Medical Problem

  MAUDE report 7862107 ↗
• MalfunctionSep 10, 2018Stretched; Unraveled Material; Stretched; Unraveled Material

  IT WAS REPORTED THAT: "4TH COIL (2MM X 3CM COMPLEX FINISH COIL) WAS STRETCHED (UNRAVELED). THE MICROCATHETER WAS DROPPED OFF FROM THE AN UNINTENTIONALLY DURING INSERTION OF THE COIL AND REMAINING 5MM COIL COULD NOT BE PLACED. THE SURGEON TRIED TO RE-INSERT THE MICROCATHETER INTO THE AN BUT IT COULD NOT BE SUCCESSFUL. SO, WHOLE COIL SYSTEM WAS REMOVED FROM THE PATIENT. SURGEON'S COMMENTS: THE SURGEON COMMENTED THAT THE SELECTION OF LONG COIL (3CM) WAS NOT PROPERLY FOR THIS CASE. UNRAVEL OF COIL MIGHT HAVE DUE TO OPERATION OF MICROCATHETER DURING RE-INSERTION."

  Patient problems: Aneurysm; Patient Problem/Medical Problem

  MAUDE report 7862104 ↗