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