FDAHealthJuly 21, 2025
SUMMA THERAPEUTICS, LLC — Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guid
⚠️ Potential for the balloon in the device to not meet burst specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 21, 2025
US Nationwide distribution in the states of New Jersey, Florida.
What's affected?
- 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
- Lot code
- 240502
Additional details
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 22 units.
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