Abiomed, Inc.: Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Domestic distribution nationwide. Quantity: n/a - no physical product Lot/code info: UDI-DI 00813502011647 Software version 1.1 - 3.17.1

UPC codes

00813502011647

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.