Recall Z-2403-2026 ยท GXI Probe, Radiofrequency Lesion
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, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NI
| Date | Jun 11, 2026 (initiated Apr 29, 2026) |
| Status | Open, Classified |
| Reason | Reusable electrodes may not meet expected performance levels. |
| Root cause | Under Investigation by firm |
| 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 aff |
| Quantity | 49,251 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. |
| FDA record | Open on fda.gov |