Intrasaccular Flow Disruption Device
FDA adverse event reports and recall history for intrasaccular flow disruption device (product code OPR), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 889
- Deaths
- 34
- Injuries
- 393
- Malfunctions
- 462
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2022-11-02Open, ClassifiedProcess control
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
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