Abiomed Automated Impella Controller Software Issue Recall

Take action

Contact the company & request your remedy

Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions V8.4 and V8.4.1 are affected.

How can I tell if my device is recalled?

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.

What should I do if I have the affected device?

The recall record does not specify a remedy, so contact Abiomed directly for guidance.

Take action

Contact Abiomed

We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0441-2024 — Abiomed Abiomed

Hello,

I own a Abiomed that is covered by recall Z-0441-2024 from Abiomed.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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.

Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Lower-risk recall