Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
FDA Recall Z-2404-2026 · Posted 2026-06-11
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Recalling FirmBoston Scientific Neuromodulation Corporation
Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2026-04-29
Product Quantity43 units
Reason for Recall
Sterile anchors my lack sterility assurance.
Firm 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 awareness and to any organization to which affected devices have been transferred.
4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions.
5. Return Affected Product.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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