Barricade Coil System 900068Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053020674), received between Sep 20, 2019 and Nov 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionNov 4, 2019Positioning Problem

  THE PHYSICIAN WAS COILING A 3MM PERI-OPTHALMIC ANEURYSM. HE PLACED A 2.5X17 LVIS AND FRAMED WITH 3X6 CSS. HE THEN PLACED A 3X4 CSS. ON THE 3RD COIL, A 2X6 CSS WAS INTRODUCED WITH THE MICROCATHETER POSITION STILL AT THE DOME OF THE ANEURYSM. THE 2ND LOOP HERNIATED OUT OF THE DOME AND ANGIOGRAPHICALLY APPEARED TO PERFORATE THE ANEURYSM. THE FELLOW PUSHING THE COIL HAD (B)(6) TAKE OVER WHERE HE MOVED THE MC POSITION AND MANIPULATED THE COIL BACK INTO THE ANEURYSM. HE DETACHED THE COIL. POST ANGIO SHOWED CONTRAST IN THE SUB A SPACE AND HE REVERSED HER HEPARIN WITH PROTAMINE. HE THEN WENT INTO THE ICA WITH A SCEPTER BALLOON AND KEPT IT UP FOR SHORT PERIODS OF TIME. POST BALLOON/PROTAMINE SHOWED NO MORE CONTRAST LEAKAGE, AND HE ENDED THE CASE. THE PATIENT WOKE POST ANESTHESIA WITHOUT ANY NEURO DEFICITS. (B)(6) THOUGHT IT WAS THE JAILED MICROCATHETER POSITION THAT CAUSED THE PERFORATION.

  Patient problems: Aneurysm

  MAUDE report 9273223 ↗
• MalfunctionSep 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AT PERFORMING A MEDICAL PROCEDURE OF INTRACRANIAL ENDOVASCULAR THERAPY FOR A BRAIN ANEURYSM WHICH WAS BROKEN, THE COIL BARRICADE 4X13 DEPLOYED BY ITSELF. IF STRETCHED AND GOT THIN. SO, THE DEPLOYED PART STAYED IN THE ANEURYSM AND CAROTID. THE PART OF THE STENT WHICH WAS POSSIBLE TO RECOVER WAS SENT BACK TO THE DISTRIBUTOR SO THAT THEY ASK THE MANUFACTURER FOR THE REGARDING ANALYSIS. AFTER THE INCIDENT A STENT WAS IMPLANTED IN ORDER TO FIX THE COIL WHICH STAYED IN THE CAROTID. FOLLOW UP SENT (8/23/2019): "DID THE DEVICE DETACH BEFORE OR AFTER A DETACHMENT CYCLE WAS INITIATED?.IT STATED THAT PART OF THE COIL STAYED IN THE ANEURYSM. DID THE COIL BREAK? WHY WAS THIS REPORTED TO INVIMA? WAS IT REPORTED BY THE HOSPITAL OR BY C.I. DISMECOL? WHAT OCCURRED WITH THE STENT?" FOLLOW UP RECEIVED (8/30/2019): " IT WAS BEFORE A DETACHMENT CYCLE WAS INITIATED. YES, THE COIL BROKE IT WAS REPORTED TO INVIMA BY THE INSTITUTION BECAUSE ACCORDING TO THEIR PROTOCOLS THEY HAD TO. IT WAS THE PHARMACEUTICAL CHEMIST'S DECISION. THE COIL STAYED PRESSED TO THE ARTERY'S WALL. THAT'S WHY IT WAS NECESSARY TO USE A STENT IN ORDER TO AVOID IT TO STAY FLOATING AND THAT IT MIGHT MIGRATE." FOLLOW UP SENT (9/4/2019):

  Patient problems: Aneurysm

  MAUDE report 9099062 ↗