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Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote
Recalled January 10, 2024 · FDA recall Z-0636-2024 · Abiomed
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 · FDA Class II
Units
n/a - no physical product
Sold at
Domestic distribution nationwide.
Description
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
Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →