Barricade Coil System 900011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053020124), received between May 8, 2018 and May 23, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 16, 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.

• InjuryMay 23, 2018Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT WHILE TREATMENT OF AN ANEURYSM LOCATED AT MCA. "THE TIP OF MC (ECHELON 10) WAS PLACED AT MIDDLE OF THE ANEURYSM AND THE COIL WAS PUSH-OUT FROM THE CATHETER. HOWEVER, THE FIRST LOOP CAME OFF FROM THE ANEURYSM, AND MICROCATHETER KICKED-BACK TO MAIN VESSEL DURING WITHDRAWAL OF THE COIL. THEN, THE SURGEON RE-INSERTED THE MICROCATHETER INTO THE ANEURYSM DEEPER THAN FIRST ATTEMPT AND TRIED TO PUSH-OUT THE COIL INTO THE ANEURYSM. WHEN ABOUT 90% OF THE TOTAL LENGTH WAS PLACED, ONE OF THE LOOP WAS CAME OFF OUT OF THE ANEURYSM AND THEN IT WAS CONFIRMED THAT THE PERFORATION WAS OCCURRED. THE SURGEON PERFORMED REVERSING OF HEPARIN AND INFLATING THE BALLOON FOR THE TREATMENT FOR THE PERFORATION. FOUR MINUTES PASSED, THE SURGEON DEFLATED THE BALLOON AND PERFORMED CONTRASTRADIOGRAPHY, IT WAS CONFIRMED THAT THE BLEEDING WAS STOPPED. FINALLY, THE COIL HAD DETACHED PROPERLY AT REVERSE "T" POSITION. THE PROCEDURE WAS COMPLETED SINCE THERE WAS NO PROBLEM FOR THE PATIENT'S SITUATION (CONSCIOUSNESS, SPEECH, VISUAL FIELD ETC.)" SURGEON'S COMMENTS: HE COMMENTED THAT HE MISTOOK THE SELECTION OF THE COIL SIZE, HE SHOULD NOT HAVE BEEN SELECTED LONG COIL. ALSO, HE COMMENTED THAT THE TIP O

  Patient problems: Aneurysm

  MAUDE report 7539551 ↗
• MalfunctionMay 8, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT A "3MM X 10CM COMPLEX FINISH COIL WAS INSERTED INTO THE AREA OF D-AVF BY USING SL-10 BUT COIL SIZE WAS UNAPPROPRIATED AND THE SURGEON TRIED TO WITHDRAW THE COIL. HOWEVER, THE PUSHER WIRE GOT STUCK AND COULD NOT BE MOVED. THE SURGEON CUT THE PUSHER WIRE TOGETHER WITH THE HUB OF SL-10 BY SCISSORS, THEN ATTACHED THE SNARE AND PULL OUT BUT THE COIL WAS UNINTENTIONALLY DETACHED ON THE HALFWAY. THEN, THE DETACHED COIL WAS PLACED WITHIN THE PATIENT AND SL-10 WAS REMOVED."

  Patient problems: Aneurysm

  MAUDE report 7495737 ↗