Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheter. The U.S. Food and Drug Administration (FDA) has classified this as a Class 1 recall, the most serious type of recall where the FDA deems a reasonable probability to exist that “use or exposure to the violative product will cause serious adverse health consequences, or death.”
The Fetch 2 Aspiration Catheter is used to clear blood clots from coronary arteries in a procedure called thrombectomy. It is a long, flexible device that pushes through the arteries and vacuums clots from vessels. This is done to remove any obstructions which then allows blood to flow more freely, according to drugwatch.
The reason for the recall is the catheter shaft may break before or during procedure, at various points along the device. If the breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels, and would have to be surgically removed.
Boston Scientific acquired the company from Bayer Medical Inc. in September 2014, so all recalled inventory packaging still has the Bayer label. Manufacturing dates for the recall are June 1, 2014 to February 19, 2016, according to the FDA website.
“All reports of shaft breakage happened during the procedure and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications,” said Boston Scientific in a statement, reports drugwatch.
The company said there have been no reports of injury or death, and patients who already underwent the procedure are not at risk.