On August 9, 2010, the FDA issued its first safety communication warning about adverse events with retrievable IVC filters. The communication cited 921 adverse event reports received between 2005 and 2010: 328 device migrations, 146 detachments (struts separating from the filter body), 70 perforations, and 56 filter fractures. The FDA recommended that physicians remove retrievable filters as soon as protection from pulmonary embolism was no longer required.

On May 6, 2014, the FDA issued an updated safety communication reiterating the removal recommendation and noting that adverse events had continued despite the 2010 warning. The agency acknowledged that the long-term risks of filters left in place had not been well characterized — a significant admission given how widely retrievable filters had been implanted. In 2015 and 2016, the FDA issued 522 post-market study orders to Bard and Cook, requiring manufacturers to conduct rigorous post-market surveillance. The 522 study results, published in 2019, confirmed fracture and perforation rates far exceeding what manufacturers had represented in original premarket submissions.