Agency classClass IOur severity:Critical FDA (Devices)·Z-0830-2025·Announced 2025-01-22

Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk

Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This product has received FDA Class I classification, the highest regulatory severity level for devices where there is a reasonable probability of serious adverse health consequences or death. Optical sensor damage in ventricular assist devices could result in temporary or permanent pump failure in patients who depend on the device for cardiac support.

Plain-English summary

The Impella RP Flex with SmartAssist is a heart pump device manufactured by Abiomed, Inc. A total of 2,364 units with specific serial numbers have been recalled (Product Number 1000323).

Abiomed identified a risk that optical sensors on these devices can be damaged through physical interaction with the inlet during insertion, manipulation, or removal of guidewires, central venous lines, or other devices. This damage can trigger a Placement Signal Not Reliable (PSNR) alarm and cause loss of Central Venous (CV), Pulmonary Artery (PA), and Pulmonary Artery Pulse Index (PAPi) monitoring signals. The optical sensor damage may result in temporary or permanent pump stop.

The affected units were distributed nationwide in the United States and in Canada. Healthcare providers should verify whether they have any of the recalled serial numbers in their facilities.

The recalled product

Product: Impella RP Flex with SmartAssist; Product Number: 1000323;
Manufacturer: Abiomed, Inc.
Category: Medical Device — Ventricular Assist Device
Hazard: optical-sensor-damage
signal-loss
pump-failure
device-interaction
Affected units: 2,364

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: 1000323
UDI-DI: 00813502012811
Serial Numbers: 551121
551122
551123
551124
551125
551127
551128
551129
537606
537610
537612
537615
537607
537608
537609
537613
537614
548547

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 · optical sensor damage