LeMaitre Over the Wire Embolectomy Catheter Recalled
The FDA announced this week that LeMaitre Vascular, Inc. is recalling over 49,000 of its Over the Wire Embolectomy Catheters that were distributed from November 7, 2014 to March 5, 2020. The LeMaitre Over the Wire Embolectomy Catheter is used to surgically remove either a blood clot, fat, or other material that has lodged in a blood vessel (embolus) or a blood clot that has formed in a vein (thrombus).
How Balloon Embolectomy Catheters are Supposed to work.
The LeMaitre Over the Wire Embolectomy Catheter is a type of balloon catheter. Balloon catheters are small, flexible tubes that have a small, inflatable balloon at the end. To remove an embolus or thrombus, a balloon catheter is inserted into a vein and moved until it is just past the embolus or thrombus. Then the balloon is inflated and the catheter is slowly pulled back, taking the embolus or thrombus with it.
Reason for the Recall:
According to the FDA, LeMaitre Vascular, Inc. is recalling the Over the Wire Embolectomy Catheter due to a risk of the balloon failing to deflate during use. The FDA stated, “If the balloon does not deflate, the tip of the catheter or the balloon could separate and block (obstruct) a patient’s blood vessel while the surgeon attempts to remove the inflated balloon catheter. This 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 reports that from January 1, 2018 to March 23, 2020, it has received 26 reports of the LeMaitre Over the Wire Embolectomy Catheter failing to work properly, with one injury. For more information regarding this recall, click here.
If you or a loved one have been injured by the LeMaitre Over the Wire Embolectomy Catheter or another medical device, the Cincinnati medical device attorneys at Burg Simpson can help. Burg Simpson has a reputation for standing up for those seriously injured by others, even against the biggest companies in the United States. Call the defective device attorneys in Burg Simpson’s Cincinnati, Ohio office today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.