Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5

Reusable electrodes may not meet expected performance levels.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2403-2026
• FDA 510(k) clearance · K050084The device's official FDA premarket clearance record
• FDA 510(k) clearance · K183177The device's official FDA premarket clearance record
• FDA device classification · GXIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific Neuromodulation CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.