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.
What this means for you
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
- Hazard
- unevaluated-software-features
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.
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