Boston Scientific Recalls Atherectomy Device Components
Boston Scientific is recalling more than 900 units of its RotaWire Elite guidewire and wireClip Torquer guidewire manipulation device — used in conjunction with the company’s Rotablator atherectomy device — following three complaints of wire fracture, including one instance in which a patient died.
According to a letter to customers, one fracture occurred during device prep, while two others took place during procedures on patients.
Boston Scientific has advised customers to stop using any remaining affected product and has provided a list of lot/batch numbers.
The FDA has designated the recall as Class I. — Michael Cipriano