Published on 18 Apr 2024 on Benzinga via Yahoo Finance
FDA Classifies Boston Scientific's Recall For Device To Stop Blood Flow As 'Most Serious'
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 investigation determined that delivery of Obsidio Embolic using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal (GI) bleeding embolization, implies a high risk of bowel ischemia.