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KGGClass 3

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA adverse event reports and recall history for tissue adhesive for use in embolization of brain arteriovenous malformations (product code KGG), from the public MAUDE corpus and the live FDA recall database.

Total reports
100
Deaths
7
Injuries
68
Malfunctions
25

Reports per year

08
11
12
13
16
17
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2008–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2014-01-23TerminatedEmployee error

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    Incorrect instructions for use (IFU).

  • 2014-01-23TerminatedEmployee error

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    Incorrect instructions for use (IFU).

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