Abiomed, Inc. Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Products Sold
UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Abiomed, Inc. is recalling Impella Connect, software portal for online device management that allows clinicians and Impella sup due to The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: No. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026