Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Recall
- Recall Number
- Z-2404-2026
- Event Number
- 98941
- Firm
- Boston Scientific Neuromodulation Corporation
- FEI Number
- 3006630150
- Product Code
- LGW
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- April 29, 2026
- Posted
- June 11, 2026
- Address
- 25155 Rye Canyon Loop, Valencia, CA, 91355-5004
Description
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sterile anchors my lack sterility assurance.
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.
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
43 units