FDA recall Z-1704-2026

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

Status

Ongoing

Initiation date

2025-07-21

Report date

2026-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allston, MA, United States

Primary source

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