Abiomed - Medical Devices
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and surgical instruments.
Lower-risk recall
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Contact the company
What happened, in plain English
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and surgical instruments. Read more at govinfonow.com/recall/51286-abiomed-medical-devices.
Source Summary by GovInfoNow · govinfonow.com/recall/51286-abiomed-medical-devices · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0136-2026
Cite this page
“Abiomed - Medical Devices.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51286-abiomed-medical-devices. Based on FDA recall #Z-0136-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2026%22&limit=1).
Why it’s dangerous
Abiomed is a reputable medical device manufacturer with a strong safety record. Their products undergo rigorous testing and regulatory compliance checks to ensure patient safety.
Who’s affected
Patients using Abiomed medical devices
How to tell if you have this one
Check for the latest product updates and safety alerts from Abiomed's official website or regulatory bodies like the FDA.
- Brand
Abiomed- Product
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect- Category
Medical device
What to do — step by step
1
Visit Abiomed's official website to review their product range and safety information.
2
Check with your healthcare provider for any specific recommendations regarding Abiomed devices.
3
Monitor regulatory updates from the FDA or other relevant health authorities for any new safety alerts.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands,…” 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 43 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-0136-2026 (September 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0136-2026 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.