Benzinga.com

FDA Classifies Boston Scientific's Recall For Device To Stop Blood Flow As 'Most Serious'

On Wednesday, Boston Scientific Corporation (NYSE:BSX) said it recalled Obsidio Embolic by issuing a correction. The FDA has identified this as a Class I recall, the most severe type of recall. An ...
MD&M East

Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization

Boston Scientific has again updated the instructions for use (IFU) and use recommendations connected to its Q124 correction of the Obsidio Conformable Embolic after reporting two additional deaths and ...
MD&M East

Boston Scientific Class I Recall Linked to Two Deaths

Boston Scientific’s Obsidio Conformable Embolic recall was recently hit with FDA’s Class I classification. The recall is categorized as a correction, not a product removal and comes after the company ...
MedPage Today

FDA Slaps Embolization Device With Class I Recall After Deaths

The Obsidio Conformable Embolic recall related to an increased risk for bowel ischemia is the most serious kind, the FDA said on Wednesday, citing two deaths associated with the issue. An ...
Yahoo

FDA classifies recall of Boston Scientific device as 'most serious'

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug ...