Abiomed Automated Impella Controller Cybersecurity Recall: Potential Vulnerabilities
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.
Recall notice
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/51129-abiomed-automated-impella-controller-cybersecurity-recall-potential-vulnerabilities.
Source Summary by GovInfoNow · govinfonow.com/recall/51129-abiomed-automated-impella-controller-cybersecurity-recall-potential-vulnerabilities · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0069-2026
Cite this page
“Abiomed Automated Impella Controller Cybersecurity Recall: Potential Vulnerabilities.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51129-abiomed-automated-impella-controller-cybersecurity-recall-potential-vulnerabilities. Based on FDA recall #Z-0069-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Abiomed- Product
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding- Category
Medical device
What to do — step by step
Check Product Details
Review the product codes and serial numbers listed in the recall notice to determine if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom of Great…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0069-2026 (October 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0069-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.