Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Impella Connect Recalled by Abiomed, Inc. Due to The following features have been disabled from the...
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
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Quantity: n/a - no physical product
Why Was This Recalled?
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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