medical Class II Updated 2024-01-10

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 00813502011647 Software version 1.1 - 3.17.1
View official government recall

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