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.
- Product
- Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
- Category
- Medical Device
- Distribution
- Distributed nationwide