Abiomed recalls Impella RP devices with product code 0046-0011 due to potential sensor malfunction causing inaccurate readings. Affected units distributed outside the US.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed is recalling Impella RP devices with product code 0046-0011 because their differential pressure sensor may malfunction, leading to inaccurate readings. This could affect medical monitoring accuracy during use.
The differential pressure sensor in these devices may give incorrect readings, which could lead to improper medical decisions. This is a potential issue for devices used in critical care settings where precise monitoring is essential.
Medical professionals using Impella RP devices with product code 0046-0011, particularly those in hospitals outside the US. Patients receiving treatment with these devices may be at risk if monitoring is inaccurate.
Check for product code 0046-0011 on the device. Units distributed outside the US are affected. The UDI-DI number 04260113630273 is also associated with this recall.
Look for product code 0046-0011 on the Impella RP device.
The recall indicates a potential sensor malfunction risk, but the device may still be used with caution. Abiomed has not provided specific instructions to stop use.
Check for product code 0046-0011. If affected, contact Abiomed for further instructions as the recall does not specify a remedy.
The recall states that sensor values may drift, which could lead to inaccurate readings. However, no specific risk of injury or serious harm is mentioned.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1471-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1471-2026 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.
