The Recall Desk
SevereFDA (Devices)·Z-0829-2025·Announced 2025-01-22

Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk

Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as Class I, which requires a minimum severity score of 4. The recall addresses a documented risk of device-device interaction causing sensor damage and complete pump malfunction, though no patient injuries have been reported.

Plain-English summary

Abiomed, Inc. is recalling 1,560 units of the Impella RP with SmartAssist cardiac support pump (Product Number 0046-0035) distributed nationwide in the United States and Canada. The FDA has classified this as a Class I recall.

The recall addresses a risk of physical interaction between the inlet of the Impella pump and the tips of guidewires, central venous lines, or other indwelling medical devices during their insertion, manipulation, or removal. Such interaction can damage the pump's optical sensors.

When optical sensors are damaged, the pump may display a Placement Signal Not Reliable (PSNR) alarm and lose its ability to transmit Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal, and Pulmonary Artery Pulse Index (PAPi) readings. Damaged sensors may result in temporary or permanent pump failure.

Patients or healthcare facilities with affected units should contact Abiomed for guidance. No patient injuries have been reported to date.

The recalled product

Product
Impella RP with SmartAssist; Product Number: 0046-0035;
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Support System
Hazard
Affected units
1,560

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Number: 0046-0035
  • UDI-DI: 00813502011869
  • Serial Numbers: 492884
  • 492882
  • 492883
  • 522056
  • 522054
  • 522055
  • 522106
  • 522107
  • 522110
  • 522111
  • 522105
  • 522109
  • 520014
  • 520017
  • 520018
  • 520019
  • 520020
  • 520021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · device interaction

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