Class II

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

Abiomed, Inc. · December 6, 2023

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.

States Affected

NATIONWIDE

Quantity Affected

n/a - no physical product

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0636-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.