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 ...
The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and Electrocautery Enhanced Delivery Systems that have been linked to three ...
The U.S. Food and Drug Administration (FDA) said it is aware that Boston Scientific Corporation (NYSE: BSX) has alerted customers to remove certain AXIOS stents and electrocautery-enhanced delivery ...
Background Despite the expanding use of flow-diverting stents (flow diverters—FDs) for middle cerebral artery (MCA) ...
Boston Scientific has recalled the Axios stent after FDA linked the device to three deaths and 167 serious injuries. The deaths were associated with use cases that were outside of the stent’s ...
Boston Scientific is running a clinical study titled “A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy With Lumen-Apposing Metal Stent for Gastric Outlet ...
The National Consumer Commission (NCC) has issued an urgent recall of AXIOS™, POLARx™, and other medical devices, following ...
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