FDA designates recall of balloon embolectomy catheter as class 1
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The FDA has identified the recall of LeMaitre Vascular’s balloon embolectomy catheter as class 1, the most serious kind, due to risk for death or injury from balloon deflation failure.
According to an alert from the agency, the company’s recall of the balloon catheter (LeMaitre Over the Wire Embolectomy Catheter) was initiated March 10, 2020, due to risk for the balloon catheter failing to deflate, causing the tip of the catheter or balloon to separate and obstruct a patient’s blood vessel during attempted removal.
The LeMaitre balloon catheter is indicated for the removal of blood clots for embolectomy or thrombectomy procedures.
The FDA alert reported that there was one injury and no deaths from the failure of this device between Jan. 1, 2018 and March 23, 2020.
The devices in question were manufactured between May 5, 2014 and July 17, 2019, and were distributed between Nov. 7, 2014 and March 5, 2020, according to the alert from the agency.