The US FDA announced a Class I recall of Abbott's Amplatzer steerable delivery sheath due to an increased risk of air embolism during cardiac catheterization. The recall affects 672 devices distributed between October 4, 2022, and February 22, 2023. Abbott reported 26 incidents and 16 injuries related to this issue, prompting the recall. Customers are advised to return unused delivery sheaths and use an alternative delivery system for future procedures.
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by Megan Brooks o www.medscape.com 07-26-2023
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