US FDA classifies Imager II catheter recall as Class I due to injury risk
BSX•The FDA classified Boston Scientific’s Imager II angiographic catheter recall as Class I, the most serious type. The company reported two serious injuries and no deaths and decided to discontinue the product line.
1. Recall classification
The FDA classified Boston Scientific’s Imager II angiographic catheter recall as Class I due to injury risk. Boston Scientific reported two serious injuries and no deaths linked to the catheter defect and decided to discontinue the Imager II angiographic catheter product line.
