SUMMA THERAPEUTICS, LLC: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Descrip
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Potential for the balloon in the device to not meet burst specifications.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of New Jersey, Florida.
- Recall initiated
- 2025-07-21
- Code info
- Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
- Product quantity
- 22 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Allston
- State
- MA
- Country
- United States
- Event id
- 98493
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