SUMMA THERAPEUTICS, LLC recalls Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS2522515…

Recall date

July 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1704-2026

FDA classification

Class II

Brand / firm

SUMMA THERAPEUTICS, LLC

Sold / distributed

US Nationwide distribution in the states of New Jersey, Florida.

Why it was recalled

Potential for the balloon in the device to not meet burst specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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