Abiomed recalls specific Impella Controllers that may cause pump stoppage or failure alarms when used with heart assist pumps. Affected units have unique product codes and serial numbers.
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Abiomed is recalling certain Impella Controllers that could stop working or trigger failure alarms when used with heart assist pumps. This poses a risk to patients relying on these devices for heart support.
The recalled controllers have a faulty Pump Driver Circuit Assembly that may cause the pump to stop working or trigger a failure alarm. This could lead to reduced heart support for patients using the device.
Patients using heart assist pumps with the recalled Impella Controllers are most at risk. Healthcare providers and patients with specific product codes and serial numbers should check if their device is affected.
Check if your Impella Controller has a Product Code starting with 0042-0000 and the listed serial numbers or regional codes (US, CA, EU, UK). The device is used with heart assist pumps.
Identify your Impella Controller's product code and serial number to see if it matches the recalled units listed in the official notice.
Reach out to Abiomed directly for assistance with the recall process if you have the affected device.
Impella Controllers with Product Codes 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, or 0042-0000-UK-L and the listed serial numbers are affected.
No, but you should check if your device is affected and contact Abiomed if you have the recalled units.
Compare your device's product code and serial number with the list provided in the official recall notice.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2568-2025 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2568-2025 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.
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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.
