PFM MEDICAL INC. recalls Multi-Snare Set: 5 mm x 125 cm

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.

On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1. Inform all customers (hospitals and clinics) and device users (physicians) who have received or used affected batches. This notification should also be shared with any organizations where the potentially affected devices have been transferred. 2. Return unused devices from the affected batches to PFM Medical, Inc. 3. Complete the enclosed Recall Response Form and email back to recall@pfmmedicalusa.com

• FDA enforcement recordOfficial FDA database entry for Z-2526-2026
• FDA 510(k) clearance · K011783The device's official FDA premarket clearance record
• FDA device classification · DXEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5150The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PFM MEDICAL INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.