Medos International Sàrl is recalling 1,343 catheter devices because of fractures in the far end of the product, where different parts are joined together in brain vessels, the FDA said April 4.
The company's neurovascular catheter, Cerebase DA Guide Sheath, is used in vascular procedures, including brain surgeries. Using the affected devices could delay surgical procedures or lead to vascular injury, hemorrhage or embolism.
Three injuries and zero deaths have been reported, according to the FDA.