Z-2211-2026Class I

Automated Impella Controller (AIC)

Name: Z-2211-2026 Automated Impella Controller (AIC)
Creator: Abiomed, Inc.
Published: 2026-04-20
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-04-20 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Automated Impella Controller (AIC); Product Code: 0042-0000-US on 2026-04-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2211-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-20
Posted: 2026-05-22
Recalling firm: Abiomed, Inc.
Product: Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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 root cause: Under Investigation by firm
Action: On April 20, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers via 1-day direct mail (US). OUS notification process will be commensurate with local requirements. Actions to be taken: 1. For the devices identified, the Abiomed servicing team will contact you to coordinate the return of the device(s) to implement necessary changes. To ensure continuity of care, hospital inventory can continue to be used. 2. Upon contact from Abiomed s field servicing team, please work with them to return the identified device(s) for the change to be implemented. Refer to Attachment 2 for list of impacted AIC serial numbers. 3. Forward to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 4. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
Quantity in commerce: 91 units
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;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2211-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2211-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-22

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)