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Open, Classified

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

FDA Recall Z-2526-2026 · Posted 2026-06-23

Recalling FirmPFM MEDICAL INC.
Recall StatusOpen, Classified
Product CodeDXE
Date Initiated2026-04-21
Product Quantity32

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.

Firm Action

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 [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of NY, MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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