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 notify any facilities that may have received the devices.
The issue occurs during stent delivery and does not affect devices that have already been implanted. Patients with implanted Axios stents should continue standard follow-up care.
The Axios Electrocautery-Enhanced Stent and Delivery System is used for endoscopic drainage of pancreatic pseudocysts and walled-off necrosis. Certain models are also indicated for gallbladder drainage in high-risk surgical patients.
The FDA issued an early alert about the issue Jan. 16.
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