FDA recall Z-2526-2026

PFM MEDICAL INC. · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution in the states of NY, MD.

Key facts

Status
Ongoing
Initiation date
2026-04-21
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

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