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Recall archive / FDA device enforcement

Automated Impella Controller (AIC); Product Code: 0042-0000-US; — FDA record Z-2211-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 20, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Reason
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.
Classification
Class I
Recalling firm
Abiomed, Inc.
Quantity
91 units
Agency-reported status
Ongoing
Source record identifier
Z-2211-2026

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityProduct 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;

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jun 3, 2026
Recall initiation date
Apr 20, 2026
Center classification date
May 22, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsAbiomed, Inc. records