Abiomed recalls Automated Impella Controllers (AIC) due to potential cybersecurity vulnerabilities in the operating system. Affected models include various international versions with specific product codes and serial numbers.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Abiomed is recalling its Automated Impella Controllers (AIC) used for left heart support blood pumps because of potential cybersecurity vulnerabilities in the operating system. This recall affects specific international models with listed product codes and serial numbers.
The recall states there are potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). These vulnerabilities could allow unauthorized access or control of the device, potentially compromising patient safety.
Patients using the Automated Impella Controller for left heart support blood pumps are affected. Medical professionals who have these devices in their care are most at risk.
Check for the product codes listed in the recall notice: 0042-0000-AU, 0042-0000-CA, 0042-0000-EU, and other specific international product codes with corresponding serial numbers.
Review the product codes and serial numbers listed in the recall notice to determine if your device is affected.
The recall states there are potential cybersecurity vulnerabilities related to the operating system, but does not specify the exact risk or how it could be exploited.
The recall does not specify any remedy or action steps, so you should check the product codes and serial numbers to see if your device is affected.
Check the product codes and serial numbers listed in the recall notice to determine if your device matches the affected models.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0069-2026 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
