Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
This recall is currently active, issued January 4, 2024. It was issued by Abiomed, Inc..
- Company
- Abiomed, Inc.
- Recall Initiated
- December 6, 2023
- Posted
- January 4, 2024
- Recall Number
- Z-0636-2024
- Quantity
- n/a - no physical product
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Root Cause
No Marketing Application
Action Taken
On December 6, 2023, the firm notified affected customers via a Correction Letter delivered by the ImpellaConnect.com portal. Customers were informed that the affected features were disabled from the web-based portal. If you have questions or concerns regarding this notice, please contact ImpellaConnect@abiomed.com and/or your local clinical field staff.