Is my Abiomed Impella Controller recalled?

The recall covers 62 units with specific product codes and software versions. Hospitals should review the recall notice and consult their biomedical engineering teams for next steps.

Which devices are affected by the recall?

Product codes 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-US, 0042-0010-EU, 0042-0010-UK, 0042-0040-CA, 0042-0040-EU and 0042-0040-AU are affected. Software versions 8.2.2 to 8.5 are included.

What should I do if I own the device?

Stop using the product immediately. Contact Abiomed or your healthcare provider for instructions.

How can I check if my device is affected?

Check the product code on the device and verify serial numbers listed in the recall. See the FDA notice for details.

When was the recall issued?

February 16, 2026, per the recall notice."},{"q":"Which countries are involved?","a":"Australia, Canada, France, Germany and Kuwait."},{"q":"How many units are involved?","a":"62 units are affected."},{"q":"Will there be a replacement or refund?","a":"Remedies are described by the manufacturer. Follow the recall instructions provided."},{"q":"Where can I find more information?","a":"Refer to the FDA enforcement recall page and the Abiomed website for instructions."},{"q":"Who should I contact?

Who should I contact for help?

Contact Abiomed or your hospital’s biomedical engineering team.

Is there a safe alternative to use now?

The recall does not specify a safe alternative. Clinician guidance should be followed for alternatives.

What is the affected software version range?

8.2.2 through 8.5 are affected."}]} ,"consumerContext":{"productBackground":"The Impella Controller is part of a heart-support system used with the Impella 5.5 pump in hospitals. It manages purge monitoring and pump status.","hazardExplanation":"A delayed purge alarm could hinder timely response to purge-system issues, potentially compromising patient safety.","industryPattern":"This recall is not described as part of a broader industry pattern.","realWorldImpact":"Hospitals must pause use until

What is the software version range affected?

8.2.2 through 8.5 are affected."}]} }]}]} }}}; sorry this part got garbled; please see the corrected structure in the final document.

What is the software version range affected?

8.2.2 through 8.5 are affected."}]} }]} } ,"practicalGuidance":{"identificationSteps":["Check product code on the device (0042-0000-CA, -EU, -UK, -US, 0042-0010-EU, -0010-UK, 0042-0040-CA, -EU, -AU)."],

HIGHFebruary 16, 2026

Abiomed Impella Automated Controller Recall 62 Units in 2026

Q: What is the hazard?

A Purge System Blocked alarm display could be delayed when used with first generation Impella 5.5 pumps, potentially delaying response to purge-system issues.

Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.

Quick Facts at a Glance

Recall Date: February 16, 2026
Hazard Level: HIGH
Brand: Abiomed
Category: Health & Personal Care
Sold At: Multiple Retailers
At-Risk Groups: GENERAL

Hazard Information

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

- Product Code: 0042-0000-CA; Impella Controller, Packaged, CA; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-EU; Impella Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-UK; Impella Controller, Packaged, UK; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-US; Impella Controller, Packaged, US; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0010-EU; Impella Optical Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-?

The Hazard

The Purge System Blocked alarm display could be delayed on the Automated Impella Controller when used with first generation Impella 5.5 pumps. Delayed alerts could hinder a clinician’s response to purge-system issues.

Reported Incidents

No injuries or incidents have been reported.

What to Do

1. Stop using the product. 2. Contact Abiomed or your healthcare provider for instructions. 3. Check if your device matches the product codes and associated serial numbers listed in the recall. 4. Follow the recall instructions provided by the manufacturer.

Contact Information

Phone: Unknown Website: Abiomed official site https://www.abiomed.com; FDA recall page https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1591-2026 Hours: Unknown

Key Facts

62 units recalled
Product codes affected: 0042-0000-CA, -EU, -UK, -US, 0042-0010-EU, -0010-UK, 0042-0040-CA, -EU, -AU
Software versions affected: 8.2.2 through 8.5
Hazard: delayed purge alarm display with first-gen Impella 5.5 pumps (0550-0008*)
Distribution: Australia, Canada, France, Germany, Kuwait

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeAutomated Impella Controller (AIC)

Product Details

Apr 2, 2027

Audi

A loss