FDA Enforcement
Class II
Ongoing
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
Recall: Z-1704-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1704-2026
- Event ID
- 98493
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SUMMA THERAPEUTICS, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- July 21, 2025
- Classification Date
- March 30, 2026
- Address
- 119 Braintree St Ste 508, Allston, MA, 02134-1851, United States
Description
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
Reason
Potential for the balloon in the device to not meet burst specifications.
Code Info
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Distribution
US Nationwide distribution in the states of New Jersey, Florida.
Quantity
22 units