Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk
Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.
- Product
- Pump 381 Pump Set (US); Product Code: 1000080;
- Category
- Medical Device
- Distribution
- Distributed nationwide