FDA Device recall Z-0636-2024
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data
- FDA Device
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data by Abiomed, citing 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;….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0636-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | US |
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
Identifiers
| code_info | UDI-DI 00813502011647 Software version 1.1 - 3.17.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.