Device product
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Z-1704-2026
Product summary
- Event
- Event 98493
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-1704-2026
Official wording
Reason: Potential for the balloon in the device to not meet burst specifications.
Code information: Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Distribution pattern: US Nationwide distribution in the states of New Jersey, Florida.
Derived failure modes
-
Unknown
Potential for the balloon in the device to not meet burst specifications.