Abiomed - Medical Device Manufacturer
Abiomed is a leading medical device manufacturer specializing in cardiovascular and surgical products. We provide innovative solutions for healthcare professionals.
Lower-risk recall
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Contact the company
What happened, in plain English
Abiomed is a leading medical device company that focuses on cardiovascular and surgical products. They are known for their innovative solutions in the healthcare industry. Read more at govinfonow.com/recall/49168-abiomed-medical-device-manufacturer.
Source Summary by GovInfoNow · govinfonow.com/recall/49168-abiomed-medical-device-manufacturer · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2360-2026
Cite this page
“Abiomed - Medical Device Manufacturer.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49168-abiomed-medical-device-manufacturer. Based on FDA recall #Z-2360-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2026%22&limit=1).
Why it’s dangerous
Abiomed is a legitimate medical device manufacturer with a strong reputation in the healthcare industry. Their products are designed to meet high standards of safety and quality.
Who’s affected
Healthcare professionals, patients, medical device users
How to tell if you have this one
Check for proper certification (e.g., FDA, CE marking), review product specifications, and verify manufacturer information on official websites.
- Brand
Abiomed- Product
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with- Category
Medical device
What to do — step by step
1
Verify the manufacturer's official website and contact information through the FDA or other regulatory bodies.
2
Check for product certifications and compliance with relevant medical standards.
3
Review the product specifications and ensure they match the intended use and patient needs.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan,…” 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 41 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.
Questions people ask
What products does Abiomed manufacture?
Abiomed specializes in cardiovascular and surgical products, including devices for heart surgery and vascular procedures.
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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-2360-2026 (May 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2360-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.