The product, the Amplatzer Steerable Delivery Sheath, delivers Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder.
Air bubbles can lead to sudden reduction in blood flow to the heart, a fast or slow heartbeat, low blood pressure, and desaturation, the FDA said. These can lead to stroke and death, which classifies the recall as Class I.
The devicemaker has reported 26 incidents, 16 injuries and no deaths related to the recall.
