FDAFDA · Food and drugs·Recall number Z-0636-2024
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Published January 10, 2024 · Recall initiated: December 6, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- Domestic distribution nationwide.
- Lot
- UDI-DI 00813502011647 Software version 1.1 - 3.17.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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