Critical Alert
Abiomed Recalls Automated Impella Controller (AIC)
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2211-2026Medical Device
Abiomed Recalls Automated Impella Controller (AIC)
Abiomed, Inc. · Class I — Most Serious
Product Description
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Reason for Recall
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.
FDA Classification
Class I — Most Serious
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.
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;
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Abiomed, Inc. is recalling a medical device classified as Class I by the FDA — the highest risk level. The recall was initiated on April 20, 2026 affecting 91 units. A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. It was distributed internationally, including the United States. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Poison & Chemical Hazards and Abiomed recalls.