Agency classClass IOur severity:Severe FDA (Devices)·Z-3148-2026·Announced 2026-09-23

Abiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect

Abiomed is recalling 5,232 Automated Impella Controllers because a purge flag component may fail, causing 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 5,232 units of the Automated Impella Controller (AIC) due to a potential defect in the purge pressure sensor assembly. The recall affects six product variations, including units packaged for the US, Canada, EU, India, Japan, and the UK.

The defect involves the failure of the purge flag component, which can lead to purge cassette recognition issues. The affected units were distributed nationwide in the United States and internationally to numerous countries, including Canada, the United Kingdom, Germany, France, Japan, and Australia.

Healthcare facilities and distributors should check their inventory for the specific serial numbers listed in the FDA recall notice Z-3148-2026. If a unit is affected, it should be removed from service and returned to Abiomed for inspection or replacement.

The recalled product

Product: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product…
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiovascular Support
Hazard: sensor-failure
functional-defect

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 Controller
Packaged
CA
Product Code: 0042-0000-CA
UDI-DI: 00813502010022
Serial Numbers: IC1324
IC1346
IC1480
IC1481
IC1543
IC1544
IC1572
IC1595
IC1598
IC1664
IC1665
IC1715
IC1769
IC1790
IC1791

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abiomed, Inc.

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Same hazard · sensor failure