Recall Z-2404-2026 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Boston Scientific Neuromodulation Corporation
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
| Date | Jun 11, 2026 (initiated Apr 29, 2026) |
| Status | Open, Classified |
| Reason | Sterile anchors my lack sterility assurance. |
| Root cause | Packaging process control |
| Action | On April 29, 2026, Boston Scientific issued a Urgent Medical Device Recall via mail. Boston Scientific ask consignees to take the following actions: 1. Do NOT use Affected Product (Table 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. 2 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. 3. Forward this notice to any healthcare professional from your organization for awa |
| Quantity | 43 units |
| Distribution | US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.