Abiomed has issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers.
In an Oct. 1 alert to customers, the manufacturer directed users to disable the affected operating systems from the network and keep them in a secure environment with restricted access to mitigate risk. The company said it found vulnerabilities that could affect the performance of the systems, which are used in hospitals to control and monitor Impella heart pumps.
“This may potentially result in loss of device control or unexpected pump stop, which can lead to a loss of hemodynamic support resulting in a life-threatening injury, permanent impairment or death,” the FDA said in an Oct. 10 notice.
All serial numbers from the following package lots are affected: 0042-0000-US, 0042-0010-US, 0042-0040-US, 1000432, and 1000201, according to the FDA alert.
No cyberattacks or patient harm events have been reported in connection with the issue as of Oct. 10. The recall alert involves a correction, not product removal, and the affected devices may continue to be used once disconnected from network access, the company said.
“Patient safety remains our priority, and all impacted customers have been notified,” a spokesperson for Johnson & Johnson — Abiomed’s parent company — said in a statement to Becker’s. “While we take steps to mitigate risks, AICs can continue to be used as intended. AICs have been in clinical use for over 15 years with no reported cybersecurity incidents to date.”
