Recall Z-2403-2026— Boston Scientific Neuromodulation Corporation

Name: FDA recall Z-2403-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-29

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2026-04-29. It names 2 FDA 510(k) clearances: K183177, K050084. Product: 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..

Recalling firm: Boston Scientific Neuromodulation Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-04-29
Firm location: Valencia, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K183177 — Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation·cleared 2019-03-08
K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KITCosman Medical, Inc.·cleared 2005-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

Reusable electrodes may not meet expected performance levels.

Data sourced from openFDA. This site is unofficial and independent of the FDA.