1. Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

    Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

    The Food and Drug Administration has categorized Abbott Laboratories’ recall of 4,800 Dragonfly OpStar Imaging Catheters as a Class I event, reflecting the potential for a problem with the device that could lead to vascular injuries. Abbott issued an urgent notice about the catheters last month to warn customers of the risk of proximal markers separating from the devices. At the time, the company had received five complaints including one case of an embolism that required further intervention. According to the FDA’s Thursday notice, no deaths have been associated with the use of the device due to the ...

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