LeMaitre Vascular: Over the Wire embolectomy catheter
LeMaitre Vascular recalled its Over the Wire embolectomy catheter in March 2020. The FDA labeled the recall as Class I in April.
The recall involved 49,393 devices, which were used in the surgical removal of blood clots that are lodged in a blood vessel and blood clots that form in the veins. The devices were recalled due to a risk of the balloon catheter failing to deflate during use. If the balloon didn’t inflate, the tip of the catheter of the balloon could separate and block a blood vessel while the surgeon attempts to remove the inflated balloon catheter. The risk could cause serious health consequences, including additional surgical procedures to remove the tip or balloon pieces, damage to the blood vessel, thrombosis or death.
The FDA received 26 medical device reports and one injury and no reported deaths, according to an April 7 FDA notice.
LeMaitre Vascular advised healthcare providers to quarantine recalled devices for return to the company.
Catheters involved in the recall were made between May 5, 2014, and July 17, 2019, and were distributed between Nov. 7, 2014, and March 5, 2020.