The U.S. Food and Drug Administration (FDA) issued a recall on Tuesday of Johnson & Johnson’s heart device, Agilis Steerable Introducer Sheath, due to a faulty valve. The notice comes after a recall by J&J in June.
The valve, designed to prevent blood from flowing back into it, is part of a device that’s used to insert and position catheters in the heart. The problem is that the valve may fail due to an improper seal of the sheath hub.
The unit Sterilmed has not received reports of adverse events due to the recalled devices.
The defective seals allow blood to leak back into the hub, which can cause the cap to fall off during the implantation process. It can also create a difference in pressure that may allow air to enter the circulatory system, the FDA said.
The recall involves the following lot numbers and models: STJ408310, STJ408309 and STJ408324. The products in question were manufactured and distributed between January 1, 2017 and May 5, 2017.
According to the FDA, the problem occurs due to a lack of glue used to reattach the cap to the hub. The FDA also says that using too much glue can block the sheath valve and render the device unusable.
The FDA has issued a Class I Recall, which means the device could lead to severe health consequences, including death. A Class I Recall is the strictest form of recall issued by the health regulator.
The FDA recommends that health care facilities and providers check their inventory to determine if they have the product, and not to use the affected product. Health care facilities are asked to return unused products to the company and to monitor patients treated with the implanted device.
Healthcare professionals are asked to report adverse events or side effects related to the use of the recalled device.