Abiomed issued a recall for 10,153 Automated Impella Controllers on October 1, 2025. The devices face potential cybersecurity vulnerabilities related to their operating system. Healthcare providers and patients should stop using these devices immediately.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves multiple models of the Automated Impella Controller, including product codes 0042-0000-AU, 0042-0000-CA, 0042-0000-EU, and others. The devices were distributed nationwide and internationally, including in Europe and Asia.
The recall stems from potential cybersecurity vulnerabilities that could compromise the functionality of the Automated Impella Controller. This risk is classified as Class I, indicating a high hazard level.
As of the report date, no injuries or incidents related to this issue have been reported. The company has taken this precautionary measure to ensure patient safety.
Patients and healthcare providers should stop using the device immediately. Contact Abiomed, Inc. or your healthcare provider for further instructions and details on the recall.
For additional information, contact Abiomed at 1-800-422-8666 or visit their website at https://www.abiomed.com.
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