The U.S. Food and Drug Administration has issued a Class I recall of the Agilis Steerable Introducer Sheath’s hemostatic valve, manufactured by Sterilmed. In the recall notice, the FDA said the valve “may valve due to an improper seal of the sheath hub.” This can allow blood to leak through the hub and cause the cap to fall off during the insertion of various cardiovascular catheters into the heart, including the interatrial septum. The affected model numbers are STJ408309, STJ408310, STJG408324, including all product lots, manufactured and distributed from Jan. 1, 2017, to May 5, 2017, according to the FDA. “The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing,” the agency’s notice, issued Tuesday, says. “Too much glue can also block the sheath valve and make the device unusable.” Sterilmed recommends that health-care facilities and providers return any unused products to the company and continue to monitor patients treated with this valve. The FDA encourages the reporting of adverse events or side effects related to these products to the agency’s MedWatch Safety and Adverse Event Reporting Program.