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BioWorld - Monday, June 1, 2026
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Home » FDA announces recall of Abbott Amplatzer sheath, correction for Abiomed Impella
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FDA announces recall of Abbott Amplatzer sheath, correction for Abiomed Impella

July 28, 2023
By Mark McCarty
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
Medical technology Regulatory Cardiovascular U.S. FDA Product recall

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