The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Abiomed Inc. Impella Connect [UDI-DI 00813502011647; Software version 1.1 - 3.17.1] [HKMD No.: 180162].

According to the FDA, 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.

For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93581

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 8 Jan 2024