The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- LeMaitre Over the Wire Embolectomy Catheter
- Catalog Numbers and Lot Numbers: See full list
- Manufacturing Dates : May 5, 2014 to July 17, 2019
- Distribution Dates: November 7, 2014 to March 5, 2020
- Devices Recalled in the U.S.: 49,393
- Date Initiated by Firm: March 10, 2020
Device Use
The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that form in the veins (thrombi).
Reason for Recall
LeMaitre Vascular, Inc. is recalling the Over the Wire Embolectomy Catheter due to a risk of the balloon catheter failing to deflate during use. 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 has received 26 Medical Device Reports, with no deaths and one (1) injury from January 1, 2018 to March 23, 2020.
Who May be Affected
Health care providers using the LeMaitre Over the Wire Embolectomy Catheter
Patients undergoing embolectomy or thrombectomy procedures with the use of these catheters