FDA-Device2024-01-10Class II
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
Sold states
Domestic distribution nationwide.
Affected count
n/a - no physical product
Manufactured in
24 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2024More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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