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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Clik X Anchor

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 Class 2 Device Recall Boston Scientific Clik X Anchorsee related information
Date Initiated by FirmApril 29, 2026
Date PostedJune 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2404-2026
Recall Event ID 98941
PMA NumberP030017 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Code Information GTIN: 08714729905318/Lot # 35107836
FEI Number 3006630150
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information ContactRenee Archie
661-949-4000
Manufacturer Reason
for Recall		Sterile anchors my lack sterility assurance.
FDA Determined
Cause 2		Packaging process control
ActionOn 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 Commerce43 units
DistributionUS Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LGW
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