Abiomed Impella RP Flex SmartAssist: Sensor Drift Risk

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Recalling firmAbiomed, Inc.22 Cherry Hill Dr, N/A · Danvers, MA 01923-2575

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Abiomed is recalling Impella RP Flex with SmartAssist devices because their pressure sensors might give incorrect readings. This could lead to improper medical treatment if the device is used without proper monitoring.

Why it’s dangerous

The differential pressure sensor in the device may malfunction, causing sensor values to drift. This means the device might not accurately measure blood pressure, potentially leading to incorrect medical decisions.

Who’s affected

Patients using the Impella RP Flex with SmartAssist device for heart support are affected. Healthcare providers who use this device are most at risk of incorrect treatment decisions.

How to tell if you have this one

Check for the product code 1000323 on the device or packaging. The UDI-DI code 00813502012811 is also associated with this recall.

Brand
Abiomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the product code 1000323 or UDI-DI code 00813502012811 on the device or packaging.

✎ GovInfoNow

Questions people ask

Is this device dangerous?

The recall indicates a potential for sensor drift, which could lead to inaccurate readings. However, the device is not immediately dangerous and does not require immediate stop-use.

What should I do if I have this device?

Check for the product code 1000323 or UDI-DI code 00813502012811. If you have the device, contact Abiomed for further instructions.

Is there a fix available?

The recall record does not specify a remedy or fix. Affected users should contact Abiomed for guidance.

Take action

Contact Abiomed

We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1470-2026 — Abiomed Abiomed

Hello,

I own a Abiomed that is covered by recall Z-1470-2026 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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Where this comes from

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.

Official source: FDA Recall #Z-1470-2026 (January 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1470-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.

Lower-risk recall