Z-0636-2024 Class II Ongoing
FDA device recall Z-0636-2024 was initiated by Abiomed, Inc. on December 6, 2023 and is designated Class II. 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 o… The recall status is ongoing. Affected quantity: n/a - no physical product.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- December 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- n/a - no physical product
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
Distribution Pattern
Domestic distribution nationwide.
Code Information
UDI-DI 00813502011647 Software version 1.1 - 3.17.1