Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
- Product
- Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
- Category
- Medical Device
- Distribution
- Distributed nationwide