Abbott recalls Amplatzer Steerable Delivery Sheath used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.- Abbott
The Abbott Amplatzer Steerable Delivery Sheath is a cardiac catheter inserted through the skin that provides a pathway for catheter-based devices to be introduced into the chambers of the heart. It is specifically used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.
Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles (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. Abbott reports 26 incidents, 16 injuries, and no deaths related to this issue.
Physicians insert the recalled device through the skin to provide a pathway for catheter-based devices to be introduced into the chambers of the heart. While the sheath is used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder, an implant designed to prevent blood clots from forming in patients with a heart arrhythmia, that device is unaffected by the recall.
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