Medical Device Recall: 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-
SUMMA THERAPEUTICS, LLC · July 21, 2025
Reason for Recall
Potential for the balloon in the device to not meet burst specifications.
Product 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
Distribution
US Nationwide distribution in the states of New Jersey, Florida.
States Affected
NATIONWIDE
Quantity Affected
22 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1704-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.