Recall Z-2402-2026 ยท GXI Probe, Radiofrequency Lesion
Boston Scientific Neuromodulation Corporation
Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x
| 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 | 31,923 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. |
| FDA record | Open on fda.gov |