Boston Scientific Neuromodulation Corporation: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Recall Summary Boston Scientific is recalling the Clik X Anchor (Model SC-4318), a sterile component used with implanted spinal cord stimulators for pain relief, because the sterility of some anchors cannot be guaranteed. The recall affects devices distributed nationwide across all U.S. states and territories. This is a Class III recall, the most serious classification for medical devices.
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Product
- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Reason
- Sterile anchors my lack sterility assurance.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a8cc8d07-2d23-4efc-bcb9-68ec230fcaca