Use caution Medical device recall · FDA · Published April 20, 2026

Abiomed Automated Impella Controller Recall: Hardware Updates Needed for Safety

Abiomed recalls Automated Impella Controller units without recent hardware updates to prevent potential motor control interruptions, startup failures, and console boot-up issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2211-2026Medical device Abiomed ›

Use caution until it’s fixed

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

Take action

Contact the company

Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling Automated Impella Controllers that haven't received recent hardware updates. These updates address risks of motor control interruptions, startup failures, and console boot-up problems due to internal component issues. Read more at govinfonow.com/recall/49459-abiomed-automated-impella-controller-recall-hardware-updates-needed-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/49459-abiomed-automated-impella-controller-recall-hardware-updates-needed-for-safety · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2211-2026

Cite this page

“Abiomed Automated Impella Controller Recall: Hardware Updates Needed for Safety.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49459-abiomed-automated-impella-controller-recall-hardware-updates-needed-for-safety. Based on FDA recall #Z-2211-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2211-2026%22&limit=1).

Abiomed, Inc. voluntarily recalled 91 Automated Impella Controllers worldwide on April 20, 2026, according to the FDA. The recall addresses potential safety concerns including motor control interruptions and startup failures due to hardware issues.

How to tell if you have it

Brand: Abiomed
Product: Automated Impella Controller (AIC)
Product Code: 0042-0000-US
UDI-DI: 00813502010022
Serial Numbers: IC2449, IC2451, IC2452, IC2453, IC2459, IC2460, IC1096, IC1142, IC1202, IC1203, IC1224, IC1231, IC1238, IC1284, IC1285, IC1390, IC1545, IC1577, IC1665, IC1708, IC1741, IC1852, IC1853, IC2029, IC2071, IC2154, IC2277, IC2278, IC2314, IC2315, IC2368, IC2369, IC2370, IC2442, IC2443, IC2444, IC2461, IC2471, IC2476, IC2477, IC2478, IC2479, IC2575, IC2989, IC3127, IC3128, IC3129, IC3130, IC3166, IC3167, IC3213, IC3223, IC3306, IC3307, IC3308, IC3309, IC3342, IC3398, IC3475, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3674, IC3675, IC3719, IC3720, IC3776, IC3812, IC3887, IC3888, IC4045, IC4060, IC1301, IC1544, IC1572, IC2686, IC2687, IC2848, IC3174, IC3269, IC3272, IC3277, IC3278, IC3281, IC3282, IC3284, IC3294, IC3783

The hazard

The FDA stated that a retrospective review identified AIC units requiring specific hardware updates to address potential safety concerns. Issues include Electrostatic Discharge coupling into the Digital Signal Processor, Compact Flash Memory Card dislodgement, improper fan wire routing, and capacitor-related issues on the Power Battery Manager.

Context

GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall (2026-08-12), Abiomed Impella CP Introducer Kit Recall (2026-06-11), and Abiomed Impella CP Set Recall (2026-05-22). Other recent recalls of similar products include HeartMate 3 System Controller Recall (2026-05-13) and Wilcox BOSS Xe: Software update required for safety (2026-04-06).

How to tell if you have this one

Check for the product code 0042-0000-US or specific serial numbers listed in the recall notice. The device is used in medical settings for heart support.

Brand
Abiomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Hardware Updates
Contact Abiomed to confirm if your device has received the required hardware updates.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 14 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas, Wyoming.

Recall timeline

FDA published this recall 44 days after the firm started it.

Apr 20, 2026Firm started the recall
May 22, 2026FDA classified it Class I
Jun 3, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there specific serial numbers affected?

Yes, the recall includes specific serial numbers listed in the notice, such as IC2449, IC2451, and others.

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Link to this recall

<a href="https://govinfonow.com/recall/49459-abiomed-automated-impella-controller-recall-hardware-updates-needed-for-safety">Abiomed Automated Impella Controller Recall: Hardware Updates Needed for Safety (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2211-2026 (April 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2211-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.