The U.S. Food and Drug Administration (FDA) has announced that Abbott is recalling its Amplatzer Steerable Delivery Sheath, a cardiac catheter used to implant the company’s Amplatzer Amulet Left Atrial Appendage Occluder. The FDA has categorized this as a Class I recall, which means using the devices “may cause serious injuries or death.”
Abbott is recalling a total of 672 devices—all distributed to customers from October 2022 to February 2023—due to a heightened risk of air bubbles, or air emboli, being introduced into patients during implantation procedures.
“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),” according to the advisory. “Air embolism can also potentially lead to serious health consequences including stroke and death.”
Abbott has received reports of 26 incidents and 16 injuries related to this ongoing issue. There have been no patient deaths. Additional details filed with the FDA can be read here.
“There is an overall reported incidedence rate of 0.77% related to observed or potential air embolism during procedures in which the Amplatzer Steerable Delivery Sheath product was used,” according to the FDA website.
What should customers do if impacted by Abbott’s Amplatzer Steerable Delivery Sheath recall?
Abbott sent a Medical Device Recall notice to customers on June 12, recommending that any unused devices be returned immediately.
Customers also are advised to “use the fixed curve TorqVue 45°x45° delivery system for future Amplatzer Amulet Left Atrial Appendage Occluder implants.”
The full advisory can be read here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.