Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Automated Impella Controller (AIC) Recalled by Abiomed, Inc. Due to Pump not detected as connected to controller due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abiomed, Inc. directly.
Affected Products
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Why Was This Recalled?
Pump not detected as connected to controller due to software issue.
Where Was This Sold?
This product was distributed to 5 states: AZ, CA, FL, NY, VA
About Abiomed, Inc.
Abiomed, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report