Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Cata
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for the balloon in the device to not meet burst specifications.
Recommended action
What to do
22 units
Product description
Potential for the balloon in the device to not meet burst specifications.