Impella Connect medical device software portal disables unevaluated features
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving the voluntary disabling of software features that lack FDA evaluation. No illnesses, injuries, or deaths have been reported. The action is precautionary to ensure only FDA-evaluated features remain available to users.
Plain-English summary
The Impella Connect software portal, manufactured by Abiomed, Inc., is a web-based system used by clinicians and healthcare facilities to remotely view and manage Impella cardiac device data. Abiomed has disabled four features of this portal because the FDA has not evaluated them for safety and effectiveness.
The disabled features are: email notifications, the AIC alarm color display on case tiles, the ability to sort case tiles by AIC alarm color, and the pump metric display on case tiles.
Healthcare facilities and clinicians using Impella Connect should be aware that these features are no longer available. No illnesses, injuries, or deaths have been reported related to these features.
The recalled product
- Product
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Software Portal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00813502011647 Software version 1.1 - 3.17.1
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abiomed, Inc.
See all →- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
Similar recalls
- HighAutomated Impella Controller Software Defect Affecting Pump Connection Detection
FDA (Devices) · 2023-12-13
- SevereAutomated Impella Controllers await four pending hardware safety updates
FDA (Devices) · 2026-06-03
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighAutomated Impella Controller Software Update Resolves Pump Recognition Issue
FDA (Devices) · 2024-02-28
- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- HighAutomated Impella Controller Software Issue Prevents Pump Detection
FDA (Devices) · 2023-12-13