All Model of Fetch 2 Aspiration Catheters Recall Due to Breakage. Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheters due to reports of shaft breakage that may occur before or during procedures at various points along the device.
If breakage occurs 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, according to the U.S. Food and Drug Administration (FDA) website.
The FDA has deemed this a class 1 recall. This is the most serious sort of classification where there is reasonable probability that “use or exposure to the violative product will cause serious adverse health consequences or death.”
The Fetch 2 Aspiration Catheter is intended to remove small blood clots from peripheral veins and coronary arteries, a procedure known as thrombectomy. The device, which is long and flexible, is pushed through the arteries, it “vacuums” clots from the vessels, removing any obstruction, allowing the blood to flow more freely, Drugwatch reports.
Bayer Medical Inc. Sold To Boston Scientific Between The Recall
Bayer Medical Inc. sold the company to Boston Scientific in September 2014, so all packaging involved in the recall still have the Bayer label. The manufacturing dates for the recall are between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to recall, reports 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.
The company said there are no reports of injury or death and patients who have already undergone procedures are not at risk, Drugwatch reports.