Agency classClass IOur severity:Severe FDA (Devices)·Z-3149-2026·Announced 2026-09-23

Abiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure

Abiomed is recalling 1,422 Impella Optical Controllers because a purge flag component may fail, causing purge cassette recognition issues.

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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly."

Plain-English summary

Abiomed, Inc. is recalling 1,422 units of the Impella Optical Controller. The recall covers 487 units distributed in the United States and 935 units distributed internationally. The affected product is identified by specific product codes and serial numbers listed in the official recall notice.

The recall is being conducted due to a potential failure of the purge flag component within the purge pressure sensor assembly. This failure may result in purge cassette recognition issues. The source text does not report any illnesses, injuries, or deaths associated with this defect.

The affected units were distributed nationwide in the United States and in numerous international markets, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, and the Middle East. Healthcare providers and facilities should check their inventory against the provided serial numbers and contact Abiomed for instructions on how to proceed.

The recalled product

Product: Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller…
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Support
Hazard: component-failure
recognition-error

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)

1. Impella Optical Controller
Packaged
AU
Product Code: 0042-0010-AU
UDI-DI: 00813502010930
Serial Numbers: IC5130
IC5131
2. Impella Optical Controller
EU
Product Code: 0042-0010-EU
UDI-DI: 00813502010961
Serial Numbers: IC12955
IC12978
IC13013
IC13027
IC13042
IC13202
IC13223
IC13228
IC6947

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

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Same hazard · component failure