BSX - FDA Classifies Boston Scientific's Recall For Device To Stop Blood Flow As 'Most Serious' | Benzinga
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.
The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy.
Use of this product with the aliquot technique may prevent blood and oxygen flow ...