# FDA recall Z-1704-2026

> **SUMMA THERAPEUTICS, LLC** · Class II · device recall initiated 2025-07-21.

## 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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1704-2026
- **Recalling firm:** SUMMA THERAPEUTICS, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-21
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2026

## Citation

> AI Analytics. FDA recall Z-1704-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1704-2026. Source: US FDA. Licensed CC0.

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