Sam Brusco, Associate Editor07.28.23
The U.S. Food and Drug Administration (FDA) has deemed Abbott’s June 12 recall of its Amplatzer steerable delivery sheath as Class I.
The sheath was recalled because of an increased risk of air bubbles introduced to patients who have procedures with the device.
Air embolism can cause injuries like acute reduction in blood flow to the heart, fast or slow heartbeat, low blood pressure, and lack of enough oxygen in the blood. Air embolism may also lead to serious health consequences, including stroke and death.
Abbott reported 26 incidents, 16 injuries, and no deaths related to the issue.
The Amplatzer steerable delivery sheath is a cardiac catheter inserted through the skin that provides a pathway for catheter-based devices to be introduced into heart chambers. It’s used to deliver the Amplatzer Amulet left atrial appendage occluder (LAAO).
Abbott advised customers to return any remaining sheaths and use the fixed curve TorqVue 45°x45° delivery system for future Amplatzer Amulet LAAO implants.
The sheath was recalled because of an increased risk of air bubbles introduced to patients who have procedures with the device.
Air embolism can cause injuries like acute reduction in blood flow to the heart, fast or slow heartbeat, low blood pressure, and lack of enough oxygen in the blood. Air embolism may also lead to serious health consequences, including stroke and death.
Abbott reported 26 incidents, 16 injuries, and no deaths related to the issue.
The Amplatzer steerable delivery sheath is a cardiac catheter inserted through the skin that provides a pathway for catheter-based devices to be introduced into heart chambers. It’s used to deliver the Amplatzer Amulet left atrial appendage occluder (LAAO).
Abbott advised customers to return any remaining sheaths and use the fixed curve TorqVue 45°x45° delivery system for future Amplatzer Amulet LAAO implants.