Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: device-interaction
optical-sensor-damage
pump-malfunction
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 →

Same manufacturer · Abiomed, Inc.

See all →

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Same hazard · device interaction