SUMMA THERAPEUTICS, LLC recalls Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Cathete…

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

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

On July 21, 2025, customers were notified via E-mail. We discovered that the burst test values recorded did not meet the specification of the safety rated burst test average of 17atm. Please review your inventory and we ask that these catheters be returned for further investigation.

• FDA enforcement recordOfficial FDA database entry for Z-1704-2026
• FDA 510(k) clearance · K230263The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241740The device's official FDA premarket clearance record
• FDA device classification · LITOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SUMMA THERAPEUTICS, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.