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SUMMA THERAPEUTICS, LLC recalls Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251
Recalled April 8, 2026 · FDA recall Z-1704-2026 · SUMMA THERAPEUTICS
Hazard
Potential for the balloon in the device to not meet burst specifications. · FDA Class II
Units
22 units
Sold at
US Nationwide distribution in the states of New Jersey, Florida.
Description
Potential for the balloon in the device to not meet burst specifications.
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
Manufacturer(s)
SUMMA THERAPEUTICS, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →