Abiomed recalls Impella RP with SmartAssist devices (product code 0046-0035) due to potential sensor value drift affecting medical monitoring.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed is recalling Impella RP with SmartAssist devices that may show incorrect sensor readings. This could lead to improper medical treatment decisions if the device is used without proper monitoring.
The differential pressure sensor may drift, causing inaccurate readings. This could lead to improper medical decisions if the device is used without proper monitoring. However, the risk is low as the device is designed for critical care and not a common household item.
Patients using Impella RP with SmartAssist devices for heart support are affected. Medical teams managing these devices are most at risk of incorrect treatment decisions.
Check for product code 0046-0035 on the device label. The device may also have a unique identifier starting with 00813502011869.
Look for product code 0046-0035 or unique identifier starting with 00813502011869 on the device.
The recall indicates a potential for sensor value drift, but the risk is low as the device is designed for critical care and not a common household item.
Check for product code 0046-0035 or unique identifier starting with 00813502011869 on the device label.
The recall does not specify a remedy, so contact 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-1469-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1469-2026 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.
