LeMaitre Catheter Recall Issued Due to Risk of Balloon Deflation And Separation

Nearly 50,000 catheters used for the surgical removal of blood clots are being recalled, due to a risk that they may become lodged in a patient’s blood vessels, requiring emergency removal surgery and increasing the risk of serious injury or death.

The FDA announced a LeMaitre Over the Wire Embolectomy Catheter recall on  April 2, warning that the balloon catheter may fail to deflate during use, which could cause an obstruction in a patient’s blood vessels.

The recall involves Over the Wire Embolectomy Catheters, which are designed for use in the surgical removal of blood clots lodged in a blood vessel, and for blood clots that form in the veins.

The devices are equipped with a balloon which inflates to allow the insertion of the catheter. In the event the balloon does not deflate, the tip of the catheter or the balloon could separate and block a patient’s blood vessels.

The catheter recall notice warns the problem could lead to serious and potentially life threatening health consequences, including emergency surgery to remove the tip of the balloon pieces, damage to blood vessels, thrombosis, or even death.

To date, the manufacturer has become aware of 26 Medical Device Reports between January 1, 2018 and March 23, 2020. Of the reports, FDA officials have learned of one injury as a result of a catheter separation.

The recall includes 49,393 LeMaitre Over the Wire Embolectomy Catheters manufactured by LeMaitre Vascular, Inc., from May 5, 2014 to July 17, 2019, and distributed to surgical centers and healthcare facilities from November 7, 2014 to March 5, 2020. The recall notice includes a full list of affected devices, including catalog numbers, lot numbers and expiration dates.

LeMaitre sent an Urgent Medical Device Recall letter to customers on March 17, 2020 informing them of the issue and instructing them to stop using the devices immediately.

On April 2, the FDA categorized the letter as a Class I recall, the most serious classification, indicating the agency believes the use of the product poses a risk of serious adverse health consequences and even death.

Customers are being asked to fill out the inventory forms and to wait for instructions on how to return the devices. Once the recalled devices have been received by LeMaitre Vascular, they will arrange for replacement material.

For additional questions or concerns regarding the recall, customers should contact Rose Lerer by email at rlerer@lemaitre.com or by phone at 781-425-1671.