Impella Connect recall
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Why was Impella Connect recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00813502011647 Software version 1.1 - 3.17.1
- Product
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Recalling firm
- Abiomed, Inc.
- Quantity
- n/a - no physical product
- Distribution
- Domestic distribution nationwide.
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)