Impella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
- Product
- Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
- Category
- Medical Device
- Distribution
- Distributed nationwide