{"url_path":"/fda/device/recalls/Z-2403-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Neuromodulation Corporation — 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, 3…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2403-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Neuromodulation Corporation"},"word_count":181,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2403-2026\n\n**Recalling firm:** Boston Scientific Neuromodulation Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-29\n**Report date:** 2026-06-17\n\n## Product\nBoston 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)\n\n## Reason\nReusable electrodes may not meet expected performance levels.\n\n## Affected lots\nAll 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\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA."}