Summary
The FDA issued a Class I for Automated Impella Controller (AIC); Product Code: 0042-0000-US; by Abiomed, Inc.. Reason: A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware up.
Details
Source
Device Recall
External ID
Z-2211-2026
Action Date
2026-06-03
Status
Ongoing
Category
device
Product Description
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Lot/Code Info: 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;
Quantity Affected: 91 units
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.
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;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-20
Company
Danvers, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 129 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2211-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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