Boston Scientific has issued an FDA warning letter recommending removal of 1,660 lots of AXIOS Stent and Electrocautery Enhanced Delivery Systems due to increased reports of stent deployment and ...
FDA flags safety risk with Boston Scientific stents after reports of deployment issues causing deaths and injuries, prompting a Class I recall.
Boston Scientific Corp BSX on Wednesday initiated the removal of certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems from clinical settings following reports of deployment complications ...
Add Yahoo as a preferred source to see more of our stories on Google. Boston Scientific's headquarters is in Marlborough, Massachusetts. (Courtesy of Boston Scientific) This story was originally ...
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 ...
Boston Scientific has issued a recall letter to users of the Axios stent after FDA linked the device to three deaths and 167 serious injuries. The deaths were linked to use cases of the stent that ...
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 RAINBOW study, officially titled “French Prospective Study on Biliary Tract Drainage Guided by Endoscopic Ultrasound in Patients With Malignant Biliary Stenosis (RAINBOW),” evaluates Boston ...
In the last month of 2015, the FDA granted 510(k) clearance to five gastroenterology and endoscopy devices. AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System ...
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