FDA Classifies Boston Scientific's Recall Of Imager II Angiographic Catheters As Class I Due To Potential Catheter Tip Degradation And Detachment Risk

The FDA has classified Boston Scientific's recall of Imager II angiographic catheters as a Class I recall due to risks associated with potential catheter tip degradation and detachment. This classification indicates that the issue poses a significant risk of serious injury or death. The recall affects the safety and efficacy of the devices, which may impact the company's reputation and sales in the medical device market.