FDA-Device2026-07-01Class II

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

Hazard

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.

Sold states
US Nationwide distribution in the states of NY, MD.
Affected count
32
Manufactured in
1916 Palomar Oaks Way, N/A, Carlsbad, CA, United States
Products
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2526-2026

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