BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2526-2026 · Initiated April 21, 2026

    Recall

    Recall Number
    Z-2526-2026
    Event Number
    98942
    Firm
    PFM MEDICAL INC.
    FEI Number
    3013666218
    Product Code
    DXE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 21, 2026
    Posted
    June 23, 2026
    Address
    1916 Palomar Oaks Way, Carlsbad, CA, 92008-5523

    Description

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

    Reason

    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.

    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]

    Distribution

    US Nationwide distribution in the states of NY, MD.

    Quantity

    32