FDAClass II · Medical device · Recalled June 17, 2026

Boston Scientific TCN Electrodes recall — Boston Scientific Neuromodulation Corporation

View the official FDA enforcement record (openFDA) ↗

Official recall ID

Z-2403-2026

Brand

Boston Scientific Neuromodulation

Classification

Class II

Units affected

49,251 units

Recall status

Ongoing

Initiated

Voluntary: Firm initiated

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)

Affected products

• Boston Scientific TCN Electrodes

Companies & origin

Recalling firm location

Valencia, CA, United States

Firm address

25155 Rye Canyon Loop, N/A, 91355-5004

Identifying details (verbatim from the notice)

Product codes / lots

All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533

Distribution

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

Firm notified the public via

Letter

FDA event ID

98939

Recall initiated

April 29, 2026

FDA classified

June 11, 2026

FDA report date

June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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