Impella CP Smart Assist Set device interaction with coronary catheters
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall involving a risk-of-harm cardiac device with no reported illnesses or injuries. The hazard is potential interaction requiring labeling updates rather than addressing known harm, fitting the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Abiomed, Inc. is recalling the Impella CP Smart Assist Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The recall affects 323 units distributed worldwide. Currently, Abiomed labeling does not contain information about this potential interaction.
This recall affects patients who may undergo coronary interventions while supported by a left-sided Impella Pump, particularly when a Shockwave Coronary IVL Catheter is used.
Healthcare providers and patients should be aware of this potential interaction when planning coronary interventions in patients using an Impella CP. Abiomed will update device labeling to inform users of this interaction.
The recalled product
- Product
- Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-interaction
- labeling-deficiency
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: 0048-0044
- UDI-DI: 00813502012200
Distribution
Distributed nationwide across the United States.
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