Abiomed recalls Automated Impella Controller units without recent hardware updates to prevent potential motor control interruptions, startup failures, and console boot-up issues.
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.
Abiomed is recalling Automated Impella Controllers that haven't received recent hardware updates. These updates address risks of motor control interruptions, startup failures, and console boot-up problems due to internal component issues.
The device has internal hardware issues that could cause motor control interruptions, startup failures, or console boot-up problems. These issues may arise from electrostatic discharge, loose memory cards, or damaged wiring, potentially disrupting life-support functions.
Healthcare providers using Abiomed Automated Impella Controllers for medical treatment are most at risk. Patients relying on these devices for critical care may be affected if the device malfunctions.
Check for the product code 0042-0000-US or specific serial numbers listed in the recall notice. The device is used in medical settings for heart support.
Contact Abiomed to confirm if your device has received the required hardware updates.
Abiomed identified potential safety issues in some Automated Impella Controllers that could cause motor control interruptions, startup failures, or console boot-up problems without recent hardware updates.
Contact Abiomed to check if your device has received the necessary hardware updates; no immediate action is required if updates have been completed.
Yes, the recall includes specific serial numbers listed in the notice, such as IC2449, IC2451, and others.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2211-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2211-2026 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
