The FDA has issued an early alert concerning specific Impella CP heart pump sets from Abiomed that are out of specification, which may result in low purge pressure events during use.

RegulatoryJuly 3, 2026

Abiomed Recalls Impella CP Sets Due to Low Purge Pressure Risk

Abiomed has recalled specific Impella CP Sets due to out-of-specification conditions that may lead to low purge pressure events.

Regulatory

June 22, 2026

Abiomed Issues Correction for Automated Impella Controllers Due to Safety Concerns

Abiomed has announced that certain Automated Impella Controllers require hardware updates to mitigate potential safety risks.

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