Class I Recall On Abbott Coronary Catheters
The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.
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A tight balloon sheath in some Abbott coronary catheters has been linked to adverse events including air embolism, thrombosis, heart attack and death. Almost 450,000 units are being recalled worldwide.
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