Abiomed recalls Impella CP Set with SmartAssist (product codes 1000080, 1000851, 0048-0014, 0048-0024-JP) due to potential persistent low purge pressure alarms and interruption of mechanical circulatory support.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Abiomed is recalling Impella CP Set with SmartAssist devices that may cause persistent low purge pressure alarms and, in some cases, interruption of mechanical circulatory support. This could affect patients relying on the device for heart support.
The device may experience low purge pressure, triggering persistent alarms. In some cases, this could lead to interruption or loss of mechanical circulatory support, which is critical for patients with heart failure.
Patients using the Impella CP Set with SmartAssist for mechanical circulatory support are most at risk. The recall affects specific product codes sold by Abiomed.
Check the product codes listed: 1000080, 1000851, 0048-0014, or 0048-0024-JP. The device is used for mechanical circulatory support in heart failure patients.
Verify your Impella CP Set with SmartAssist has one of the product codes: 1000080, 1000851, 0048-0014, or 0048-0024-JP.
The Impella CP Set with SmartAssist may experience low purge pressure, causing persistent alarms and, in some cases, interruption of mechanical circulatory support.
Check the product codes listed in the recall notice to see if your device is affected. If it is, contact Abiomed for further instructions.
The recall states that interruption of mechanical circulatory support could occur, which is critical for patients with heart failure. However, the remedy is not specified in the record.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2457-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2457-2026 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.
