SUMMA THERAPEUTICS, LLC recalls Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter
- Recalling company
- SUMMA THERAPEUTICS, LLC
- 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
- Reason
- Potential for the balloon in the device to not meet burst specifications.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 21, 2025
- Reported
- Apr 8, 2026
- Distribution
- US Nationwide distribution in the states of New Jersey, Florida.
- Status
- Ongoing
- Quantity
- 22 units
- Lot / codes
- Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
- Company location
- Allston, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1704-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1704-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.