Impella 5.5 SmartAssist S2 Labeling Updated for Shockwave Catheter Interaction
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
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 Class II recall addressing a potential device interaction in a critical cardiac setting. Although no illnesses or injuries have been reported and the hazard is theoretical, it represents a risk-of-harm scenario requiring preventive labeling updates per the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
The Impella 5.5 SmartAssist S2 Set (Product Code 1000459) is a cardiac assist device manufactured by Abiomed, Inc. A total of 286 units have been distributed worldwide, including throughout the United States and internationally to countries such as Australia, Canada, France, Germany, Japan, and the United Kingdom.
A potential device interaction has been identified between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Abiomed's current labeling (Instructions for Use) does not contain information regarding this potential interaction. Abiomed is updating the device Instructions for Use to include information about this potential device interaction.
Healthcare providers using the Impella 5.5 SmartAssist S2 should be aware of this potential interaction with the Shockwave Coronary IVL Catheter. Facilities should review updated labeling once available and ensure clinical staff are informed of this interaction when both devices are being considered for use in coronary intervention procedures.
The recalled product
- Product
- Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
- 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: 1000459
- UDI-DI: 00813502013054
Distribution
Distributed nationwide across the United States.
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