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Early Alert: Heart Pump Controller Issue from Abiomed
The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Automated Impella Controllers (AIC) be removed from where they are used or sold. While awaiting service from Abiomed, hospital inventory can continue to be used to ensure continuity of care.
Abiomed stated that a retrospective review of servicing records identified certain Impella Controllers that require hardware, firmware, and/or software updates to address quality issues with the potential for safety implications. These quality issues include a potential failure of the AIC to recognize the purge cassette during setup or change; a sticking, unreliable button that could impact the operator’s ability to select and confirm menu entries and possible loss of control of the console; an instability that could result in start-up failure; and other software defects. Without the hardware, firmware, and/or software updates, patients could face various problems such as delay of therapy, inadequate or loss of hemodynamic result, and other serious issues.
As of September 8, 2026, Abiomed has reported no serious injuries or deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, questions about this issue, or if the Serial Number is missing or illegible, should contact the Abiomed Field Service Team, 1-800-422-8666, option 3 (or email ra-abm-fieldaction@its.jnj.com) for assistance.
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