Cybersecurity Triggers Another Recall of J&J’s Impella Heart Pump Controller

Cybersecurity triggers another recall of J&J’s Impella heart pump controller

While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.

Most serious FDA recall issued for Abiomed heart pump controllers

The Food and Drug Administration has identified a Class I recall of Abiomed Automated Impella Controllers due to the potential for serious injury or death. The FDA said Abiomed found cybersecurity vulnerabilities related to network and physical access that could be compromised and result in the product being exploited by a loss of control or having an unexpected pump stop. To date, no cyberattacks or incidents of patient harm due to the vulnerab…

Impella Heart Pump Cybersecurity Risks Result in FDA Recall Warning

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