Abbott is recalling the Amplatzer steerable delivery sheath, used to deliver the Amplatzer Amulet left atrial appendage occluder during cardiac catheterization, because of an increased risk of air embolism, the US Food and Drug Administration (FDA) has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA says in a recall notice on the site.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from October 4, 2022, to February 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45°x45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
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