Automated Impella Controller (AIC); Product Code: 0042-0000-US;

FDA device recall Z-2211-2026 · posted 2026-05-22 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OZD

Quantity affected

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, UA

Date initiated

2026-04-20

Date posted

2026-05-22

Location

Danvers, MA