Z-2404-2026Class II

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

Name: Z-2404-2026 Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Creator: Boston Scientific Neuromodulation Corporation
Published: 2026-04-29
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2026-04-29 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 on 2026-04-29. FDA classified it as Class II and gives the reason as "Sterile anchors my lack sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2404-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-29
Posted: 2026-06-11
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Sterile anchors my lack sterility assurance.
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 43 units
Distribution: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Product codes and lots: GTIN: 08714729905318/Lot # 35107836

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2404-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2404-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-11

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)