Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

FDA device recall Z-2404-2026 · posted 2026-06-11 · Open, Classified

Recall details

Recalling firm

Boston Scientific Neuromodulation Corporation

Reason for recall

Sterile anchors my lack sterility assurance.

Action taken

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

Status

Open, Classified

Product code

LGW

Quantity affected

43 units

Distribution

US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

Date initiated

2026-04-29

Date posted

2026-06-11

Location

Valencia, CA