Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to be introduced into patients who have procedures with this device. Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat (tachycardia or bradycardia), low blood pressure (hypotension), and lack of enough oxygen in the blood (desaturation). Air embolism can also potentially lead to serious health consequences including stroke and death.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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