LeMaitre Vascular Inc. is initiating a recall of its over the wire embolectomy catheter due to risk of the device not deflating as intended.
The U.S. Food and Drug Administration classified LeMaitre's action as a class I recall, the most serious type, noting that the use of these devices may cause serious injuries or death. According to the FDA, there was one injury reported with no deaths during the Jan. 1, 2018, to March 23, 2020, period.
LeMaitre's over the wire embolectomy catheters are used for the surgical removal of blood clots lodged in a blood vessel, along with blood clots that form in the veins. If the balloon does not deflate, the catheter's tip or the balloon may separate and block the patient's blood vessel.
There were about 49,393 devices included in the recall. These were distributed within Nov. 7, 2014, to March 5, 2020.
The company advised its customers to quarantine the recalled catheters while the company sends out instructions on how to return the devices.