Class I U.S. Food and Drug Administration

Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction

Recall published 8 months ago

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1470-2026
Published
March 11, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abiomed, Inc.
Product type
Medical devices
Units affected
4,496 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Code: 1000323. UDI-DI: 00813502012811.

Products covered by this recall

Impella RP Flex with SmartAssist. Product Code: 1000323.

What to do about Malfunction

Abiomed, Inc. — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  3. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  4. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Abiomed, Inc. — 22 Cherry Hill Dr, Danvers, MA, 01923-2575

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abiomed, Inc. medical devices recalled?

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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