Vascular Solutions (NSDQ:VASC) said today it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism.
The Minneapolis, Minn.-based company said the FDA labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The recall only affects the Guardian II hemostasis valves and does not include Guardian II NC hemostasis valves, the company said in a press release, saying air embolisms in the recalled valve could potentially result in serious injury or death.
Vascular Solutions said it has not received any reports of injury or adverse events related to the issue to date, and instructed healthcare facilities with affected units to remove the products from their inventory and return them to the company.
A total of 26,550 devices were affected by the recall, manufactured between March 2015 and February 2016 and distributed between April 2015 and February 2016, the company said.
The recalled products are specific lots of model numbers 8210 and 8211, with 5,283 units distributed in the U.S. Only approximately 2.4% of the devices are affected by the recall, Vascular Solutions said.
The recall was voluntarily initiated by Vascular Solutions on March 3 through an urgent medical device recall notification distributed to purchasers of the affected products.