FDA Medical Device Recalls (openFDA)
Boston Scientific Neuromodulation Corporation: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Recall number
- Z-2404-2026
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Product
- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Status
- Open, Classified
- Initiated
- 2026-04-29
- Posted
- 2026-06-11
- Terminated
- not on file
- Reason
- Sterile anchors my lack sterility assurance.
- 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
- 43 units
- Distribution
- US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
- Lot, serial or model codes
- GTIN: 08714729905318/Lot # 35107836
- 510(k) numbers
- not on file
- PMA numbers
- ["P030017"]
- Product code
- LGW
- Firm FEI
- 3006630150
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28