Burlington, Mass.–based LeMaitre Vascular’s Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that form in veins (thrombi). The peripheral vascular disease device maker issued the recall after discovering the risk of the balloon catheter failing to deflate during use.
If the balloon in the catheter does not deflate, the tip of the catheter or balloon could separate and block a blood vessel while a surgeon attempts to remove the catheter. If this happens, it could cause serious health consequences, including additional surgical procedures to remove the tip or pieces, damage to the blood vessel, thrombosis or death.
Users are urged to immediately quarantine any recalled devices. LeMaitre said it will send instructions for returning devices and, once they are received, the company said it will arrange for replacement material.
LeMaitre manufactured the affected products between May 5, 2014, and July 17, 2019, and distributed them between Nov.7, 2014, and March 5, 2020. The company initiated the recall on March 10, 2020 and recalled a total of 49,393 devices in the U.S.
According to an FDA notice, the administration received 26 medical device reports with one injury and no deaths recorded from Jan. 1, 2018, to March 23, 2020.