BEUDAMED
    FDA Enforcement Class II Ongoing

    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

    Recall: Z-1871-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1871-2026
    Event ID
    98463
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    March 3, 2026
    Classification Date
    April 17, 2026
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

    Reason

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

    Code Info

    SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); UDI-DI: 25051684010112(Box), 15051684010115(Pouch); Lot No.: A2825021, A2825129, A3325027, A3425027, A3525014, A3825095;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.

    Quantity

    5155 units (1031 boxes)