Impella 5.5 Cardiac Pump Labeling Updated for Device Interaction Risk
Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.
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 addressing a labeling deficiency with no reported adverse events or injuries. The issue involves a potential device interaction that requires documentation clarification rather than a device malfunction or reported harm.
Plain-English summary
The Impella 5.5 with SmartAssist Set is a cardiac pump designed to provide mechanical support during coronary interventions. Abiomed, Inc. is notifying users of an update to the device's labeling and instructions for use.
The update addresses a potential device interaction between the Impella 5.5 pump and the Shockwave Coronary IVL Catheter that may occur during coronary procedures. The current device documentation does not include information about this interaction. Abiomed is updating the Instructions for Use to provide guidance on this potential interaction.
This notice affects 21 units of the Impella 5.5 with SmartAssist Set that have been distributed worldwide, including locations in the United States, Australia, and multiple European, Asian, and other international markets.
Healthcare providers should review the updated labeling when using the Impella 5.5 pump, particularly when using it in conjunction with the Shockwave Coronary IVL Catheter or other coronary intervention devices.
The recalled product
- Product
- Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-interaction
- inadequate-labeling
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 (2)
- Product Code: 0550-0004
- UDI-DI: 00813502010466
Distribution
Distributed nationwide across the United States.
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