Tag: automated_impella_controller

FDA Issues Early Alert on Abiomed Heart Pump Controller Quality Issues

23 Sep 2026 3:22 p.m. · Source: US Food and Drug Administration

Abiomed has told customers to remove certain Automated Impella Controllers from use or sale over hardware, firmware and software quality issues, though hospital inventory can still be used.

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FDA Alerts Public to Heart Pump Controller Issue from Abiomed

21 May 2026 8:04 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding Abiomed's Automated Impella Controller, which may restart due to a software error, causing a temporary halt in heart pump support for patients. Abiomed has released updated use instructions.

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