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Abiomed’s latest Impella recall related to 129 injuries, 49 death reports

Abiomed recalled its Impella pumps due to the risk of catheter rupture through the left ventricle wall, posing serious health risks, per the FDA. Over 66,000 devices distributed in the U.S. between October 2021 and October 2023, including Impella 2.5, CP, 5.0, 5.5, and LD models, are affected. Another 26,000 devices internationally are included in the recall.

Updated instructions advise caution during catheter advancement and in high-risk patients, with enhanced imaging recommendations. Despite the recall, Abiomed maintains the availability of Impella heart pumps for patients. Previous issues include recalls for Impella RP Flex pumps due to blood clotting and interactions with transcatheter aortic valve replacement stents. A recall in April 2023 highlighted purge leaks in Impella 5.5 pumps with SmartAssist.

A warning letter from the FDA cited delays in addressing complaints and the use of unapproved software in Impella pumps, prompting Abiomed to collaborate with the FDA. J&J acquired Abiomed for $16.6 billion in 2022.