FDA recall Z-0636-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-12-06

Report date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2024