Class 1 Recall of Boston Scientific Fetch 2 Aspiration CatheterApr 28, 2016
The U.S. Food and Drug Administration (FDA) has recalled the Boston Scientific Fetch 2 Aspiration Catheter due to complaints of shaft breakage, reports Nasdaq. This is the most serious type of classification where which indicates there is reasonable probability that "use or exposure to the product will cause serious adverse health consequences or death," according to the FDA.
If breakage should occur while the device is in a patient, pieces of the catheter may interfere with blood supply to the heart and would have to be removed surgically, reports the U.S. Food website.
The Fetch 2 Aspiration Catheter is a device meant to remove blood clots from peripheral veins and coronary arteries. This is a procedure known as thrombectomy. The device is a long and flexible tube that is propelled through the arteries, and "vacuums" clots from the vessels, removing any obstruction allowing the blood to flow more freely, Drugwatch reports.
Bayer Medical Inc. sold the company to Boston Scientific in September 2014 so all recalled inventory packaging 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," Boston Scientific said in a statement. Boston Scientific said there are no reports of injury or death and patients who have already undergone procedures are not at risk, drugwatch reports.