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AHA - American Hospital Association

05/22/2026 | News release | Distributed by Public on 05/22/2026 10:54

FDA issues alert for Abiomed heart pump controllers

The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.

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AHA - American Hospital Association published this content on May 22, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 22, 2026 at 16:54 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]

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