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Open, Classified

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

FDA Recall Z-1704-2026 · Posted 2026-03-30

Recalling FirmSUMMA THERAPEUTICS, LLC
Recall StatusOpen, Classified
Product CodeLIT
Date Initiated2025-07-21
Product Quantity22 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241740Finesse Injectable™ PTA Balloon Dilatation CatheterSumma Therapeutics · 2024-07-16K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC · 2023-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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