BEUDAMED
    FDA Recall Open, Classified

    Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

    Recall: Z-2403-2026 · Initiated April 29, 2026

    Recall

    Recall Number
    Z-2403-2026
    Event Number
    98939
    Firm
    Boston Scientific Neuromodulation Corporation
    FEI Number
    3006630150
    Product Code
    GXI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 29, 2026
    Posted
    June 11, 2026
    Address
    25155 Rye Canyon Loop, Valencia, CA, 91355-5004

    Description

    Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

    Reason

    Reusable electrodes may not meet expected performance levels.

    Action

    On April 29, 2026, Boston Scientific issued a Urgent Medical device Removal Notification via Federal Express/email/hand delivery. Boston Scientific asked consignees to take the following actions: 1. DO NOT use affected product. Remove affected products from your facility s inventory, and segregate the units in a secure place. 2. For products already in use, immediately discard according to your facility s procedure. 3. Unused products should be returned to Boston Scientific in accordance with the enclosed instructions. 4. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 5. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. 6. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions.

    Distribution

    Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

    Quantity

    49,251 units