FDA Safety Communication: Abiomed's Automated Impella Controllers (AIC) Potential High-Risk Issue

On July 1, the FDA issued a safety communication as part of its pilot program to enhance medical device recalls, warning healthcare providers of a potentially high-risk issue involving Abiomed’s Automated Impella Controllers (AIC). These controllers are used with the Impella heart pump system, which provides temporary heart support in patients with critical cardiac conditions. Abiomed has identified a problem in which the AIC may fail to detect a connected Impella pump, with no visible alarms to alert users. This malfunction could result in inadequate blood flow support, particularly endangering patients in cardiogenic shock.

Abiomed sent a notice to customers on June 23 advising facilities to always have a backup AIC available. Specific troubleshooting steps were also provided, including switching to a previous or alternative console if the screen does not progress during pump connection. As of June 13, three deaths have been reported in association with this issue, though no serious injuries have been confirmed. The FDA is actively reviewing the situation and will provide updates as more information becomes available. Healthcare providers are urged to review and distribute the safety notice internally and to any facilities where affected devices may have been forwarded.