Abiomed recalls Automated Impella Controllers (AIC) used in left heart support pumps due to potential failure to detect connected pumps. Affected models include various international versions with specific product codes and serial numbers. No remedy is listed in the recall notice.
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Abiomed is recalling Automated Impella Controllers (AIC) used in left heart support blood pumps because they may not detect when an Impella pump is connected. This could lead to improper function of the heart support system. The recall includes specific international models with product codes and serial numbers listed in the notice.
The recall states that the Automated Impella Controller (AIC) may not detect an Impella pump when it is connected. This could result in the heart support system not functioning properly, potentially causing complications for patients relying on the device.
Patients using left heart support blood pumps with the recalled Automated Impella Controllers are most at risk. The recall affects specific international models sold in Australia, Canada, Europe, India, Japan, and the United States.
Check if your device has a product code starting with 0042-0000 or 0042-0010 or 0042-0040, and a serial number listed in the provided serial numbers for your country. The recall includes specific international models with different product codes and serial numbers.
Identify your product code and serial numbers from the list provided in the recall notice to determine if your device is affected.
Abiomed is recalling Automated Impella Controllers (AIC) used in left heart support blood pumps because they may not detect when an Impella pump is connected.
The affected models include specific international versions with product codes starting with 0042-0000, 0042-0010, or 0042-0040, and serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so you should check with Abiomed directly for further instructions.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2164-2025 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2164-2025 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.
