Abiomed Automated Impella Controller Software Issue Recall
Abiomed recalls Automated Impella Controller (AIC) models with software versions V8.4 and V8.4.1 due to pump connection detection failure. Affected units may not properly detect the pump, risking improper operation.
Lower-risk recall
Pump not detected as connected to controller due to software issue.
Contact the company
What happened, in plain English
Abiomed is recalling Automated Impella Controllers with specific software versions because the device may not detect the pump properly. This could lead to improper operation of the medical device, potentially causing harm to patients. Read more at govinfonow.com/recall/57108-abiomed-automated-impella-controller-software-issue-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/57108-abiomed-automated-impella-controller-software-issue-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0441-2024
Cite this page
“Abiomed Automated Impella Controller Software Issue Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57108-abiomed-automated-impella-controller-software-issue-recall. Based on FDA recall #Z-0441-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2024%22&limit=1).
Why it’s dangerous
The software issue prevents the controller from detecting if the pump is connected. This could cause the device to operate incorrectly, potentially leading to improper heart support for patients.
Who’s affected
Patients using the Automated Impella Controller for heart support are most at risk. Healthcare providers who use this device in medical settings may also be affected.
How to tell if you have this one
Check for product number 0042-040-US with software versions V8.4 or V8.4.1. Serial numbers IC8386, IC8391, and IC8617 are also affected.
- Brand
Abiomed- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: AZ, CA, FL, NY & VA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0440-2024 | Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.; UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404. | — |
| Z-0441-2024 | Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.; UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617. | — |
What to do — step by step
Check Device Software Version
Review the software version on your Automated Impella Controller. If it is V8.4 or V8.4.1, it is affected.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “US: AZ, CA, FL, NY & VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, New York, Virginia.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0441-2024 (October 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0441-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.