Recall Z-0636-2024— Abiomed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abiomed, Inc., initiated 2023-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.. Reason: 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.
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-06
- Firm location
- Danvers, MA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.