Marlborough, Mass.-based Boston Scientific’s catheters are designed to provide a pathway for delivering contrast agents to blood vessels including carotid arteries.
According to the FDA’s recall notice, there is potential for the catheter tip to become detached during a patient procedure or during procedure preparation. Use of the affected product may lead to additional surgical intervention to remove the catheter tip in the blood vessel, leading to increased time in the hospital. Other potential outcomes include serious adverse events like obstruction of blood flow (embolism), stroke or death.
Boston Scientific initiated the recall on Feb. 11, having distributed affected devices between July 16, 2018, and Nov. 26, 2019. There have been 6,130 devices recalled in the U.S. and nine reported injuries.
The company urged users to remove any affected lots in the hospital inventory, stop using any product with the affected lot number and return the affected products to Boston Scientific. The affected lots are listed below:
|Product Description||Outer Package UPN #||Inner Package UPN #||GTIN||Lot/Batch #||Expiration Date|