Adverse Events With IVC Filters Could Lead to More Regulation

Makers of inferior vena cava (IVC) filters are coming under increased scrutiny as an FDA working group looks into the growing number of adverse events involving the devices. Since 2005, the FDA has received 921 adverse event reports associated with the filters, which are small, cage-like devices used to capture blood clots in the main vessel returning blood from the lower half of the body to the heart. The working group plans to analyze the adverse trends for another year before recommending policy or regulatory changes for the Class II devices.
Devices & Diagnostics Letter