Abiomed Impella CP SmartAssist Pumps Recalled Due to Failed Inspections
Abiomed recalls 9 Impella CP SmartAssist blood pumps (Product No. 1000080) that failed inspection. These pumps may have been released without proper safety checks.
Recall notice
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Contact the company
What happened, in plain English
Abiomed is recalling nine specific Impella CP SmartAssist blood pumps that failed inspection. These pumps could have been released without proper safety checks, posing a risk to users. Read more at govinfonow.com/recall/54961-abiomed-impella-cp-smartassist-pumps-recalled-due-to-failed-inspections.
Source Summary by GovInfoNow · govinfonow.com/recall/54961-abiomed-impella-cp-smartassist-pumps-recalled-due-to-failed-inspections · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2319-2024
Cite this page
“Abiomed Impella CP SmartAssist Pumps Recalled Due to Failed Inspections.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54961-abiomed-impella-cp-smartassist-pumps-recalled-due-to-failed-inspections. Based on FDA recall #Z-2319-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2024%22&limit=1).
Why it’s dangerous
The pumps failed inspection and were inadvertently released, meaning they may not meet safety standards. This could lead to improper function or failure during use, potentially causing harm to the patient.
Who’s affected
Patients using the recalled Impella CP pumps for left heart support are affected. Those with the specific product numbers listed are most at risk.
How to tell if you have this one
Check for the product number 1000080 (REF 0048-0003) on the pump. The specific serial numbers 504354 through 504363 are also listed in the recall.
- Brand
Abiomed- Category
Medical device
What to do — step by step
Check Product Details
Verify the product number and serial numbers listed in the recall to confirm if your pump is affected.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “Domestic only: FL, MA, OH TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Massachusetts, Ohio, Texas.
Recall timeline
FDA published this recall 54 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-2319-2024 (May 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2319-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.