Agency classClass IOur severity:Severe FDA (Devices)·Z-1591-2026·Announced 2026-04-08

Impella controller purge blocked alarm may be delayed on older pumps

Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.

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 rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.

Plain-English summary

The Automated Impella Controller (AIC) is being recalled, covering the packaged controller for Canada (product code 0042-0000-CA), the EU (0042-0000-EU) and the UK (0042-0000-UK). About 62 units were distributed internationally to Australia, Canada, France, Germany and Kuwait.

There is potential that the "Purge System Blocked" alarm display on the Automated Impella Controller could be delayed when using first generation Impella 5.5 pumps. The FDA has classified this recall as Class I, its most serious category.

All products with software version 8.2.2 through 8.5 are affected, across the GTINs and serial numbers listed in the FDA enforcement record.

Facilities can identify affected controllers by the product code and software version above, and may contact the recalling firm for further information.

The recalled product

Product: Automated Impella Controller (AIC), labeled as the following with 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, UK…
Manufacturer: Abiomed, Inc.
Category: Medical Device — Circulatory support
Hazard: alarm-delay
purge-system
circulatory-support
class-i-recall
Affected units: 62

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)

GTIN: 00813502011272
Serial Numbers: IC2035
IC9416. 2. Product Code: 0042-0000-EU
GTIN: 00813502011289
Serial Numbers: IC1677
IC3049
IC3099
IC3102
IC4358
IC4329
IC5774
IC5757
IC6580
IC6581. 3. Product Code: 0042-0000-UK
GTIN: 00813502011296
Serial Numbers: IC2023
IC1910
IC2704
IC3325
IC3312. 4. Product Code: 0042-0000-US

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Abiomed, Inc.

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Same hazard · alarm delay