Abiomed, Inc. recalls Impella Connect, software portal for online device managemen
Recalled Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Hazard / Issue
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
Issued by
FDA
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