The FDA has classified Boston Scientific’s removal of certain Axios Stent and Electrocautery-Enhanced Delivery Systems as a Class I recall, the agency’s most serious designation.
The recall stems from increased reports of deployment and expansion issues during stent placement. As of Dec. 23, three deaths and 167 serious injuries had been reported in connection with the issue, according to the FDA.
Boston Scientific notified customers Dec. 19 and instructed them to immediately stop using and distributing the affected products, remove them from inventory and return them. Providers were also advised to post recall notices and…
