Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.
- Product
- Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
- Category
- Medical Device
- Distribution
- Distributed nationwide