Class I (most serious) Medical Device Z-2211-2026 Ongoing

FDA Class I recall: Abiomed Automated Impella Controller (AIC) units requiring hardware updates

Abiomed, Inc. ・Reported Jun 3, 2026

The U.S. Food and Drug Administration (FDA) classified a recall of Abiomed's Automated Impella Controller (AIC) as Class I, its most serious category. A retrospective review identified AIC units that require specific hardware updates to address potential safety concerns.

Recall overview (primary data)

ClassificationClass I (most serious)
Product typeMedical Device
Recalling firmAbiomed, Inc.
ReasonA 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.
DistributionWorldwide - 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, UA...
Recall initiated2026-04-20

Key points

On June 3, 2026, the FDA classified a recall of Abiomed's Automated Impella Controller (AIC, product code 0042-0000-US) as Class I, its most serious category.
Impella is a circulatory support device that temporarily assists the heart's pumping function, and the AIC is the controller that operates it.
The reason is that a retrospective review identified AIC units requiring specific hardware updates to address potential safety concerns.
The recall covers 91 units and is listed as Ongoing.
Distribution includes U.S. states such as CA, CT, FL, LA, MA, MI, MO, MS, and ND.

Impella is a type of medical device known as a circulatory support device, which temporarily assists the heart's pumping function. It works as a pump that moves blood through a cardiac catheter, supporting circulation in situations where heart function is reduced. The device subject to this recall, the Automated Impella Controller (AIC), is the controller that manages and operates this pump; its product code is recorded as 0042-0000-US.

The FDA's "Class I" designation is the most serious of its recall severity categories, used when the use of a product may lead to serious health consequences. According to the record, the reason for this recall is that a retrospective review (an after-the-fact inspection and verification) identified AIC units requiring specific hardware updates to address potential safety concerns. The report date is June 3, 2026, and the status is listed as Ongoing.

The recall covers 91 units, with distribution including U.S. states such as California, Connecticut, Florida, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, and North Dakota. Because the recall involves a device used for cardiac circulatory support, it is information that healthcare facilities handling the relevant equipment should be aware of from a safety standpoint.

Why it matters

This is a Class I recall involving a device used for cardiac circulatory support, making the identification of affected units (91 units) and the status of required hardware updates an important practical concern for healthcare facilities and the teams responsible for procurement and maintenance. Because the status is Ongoing, continued monitoring of the affected scope and remediation progress is warranted.

FAQ

What is a Class I recall?

It is the most serious of the FDA's recall severity categories, used when the use of a product may lead to serious health consequences.

What is the Automated Impella Controller (AIC)?

Impella is a circulatory support device that temporarily assists the heart's pumping function, and the AIC is the controller that manages and operates that pump. Its product code is recorded as 0042-0000-US.

Why was the recall initiated?

According to the record, a retrospective review identified AIC units requiring specific hardware updates to address potential safety concerns.

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA#Class I recall#Medical device#Abiomed#Impella#Circulatory support device#Cardiac

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