Abiomed recalls Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to pump connection detection failure. Affected units have specific product numbers and serials. No remedy is listed in the recall notice.
Pump not detected as connected to controller due to software issue.
Abiomed is recalling Automated Impella Controllers with software versions V8.4 and V8.4.1 because the software fails to detect if the pump is connected to the controller. This could lead to improper operation of the medical device.
The software issue causes the controller to not detect when the pump is connected. This could result in the device not functioning properly during critical medical procedures.
Patients using this medical device and healthcare providers who manage it are affected. Those with the specific product numbers and software versions listed are most at risk.
Check for product number 0042-000-US with software versions V8.4 or V8.4.1. Affected units have serial numbers IC3772, IC3773, IC5721, or IC4404.
Verify the product number and software version on your device to see if it matches the recalled items.
The recall notice does not mention any remedy or fix for this software issue.
The recall notice does not specify any action steps for affected users.
Check for product number 0042-000-US with software versions V8.4 or V8.4.1 and serial numbers IC3772, IC3773, IC5721, or IC4404.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0440-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0440-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
