FDA Medical devices recall ·
Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon… recall
- Recall number
- Z-1704-2026
- Date
- (initiated July 21, 2025)
- Company / brand
- Summa Therapeutics, LLC
119 Braintree St Ste 508, Allston, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Potential for the balloon in the device to not meet burst specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Florida New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1704-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.