FDA-Device2023-06-21Class II
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Hazard
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Sold states
US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND
Affected count
21,533
Manufactured in
25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Products
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1972-2023More Boston Scientific Neuromodulation Corporation recalls
- FDA-Device2026-06-17Boston Scientific CSK Electrodes recalled for substandard performance
- FDA-Device2026-06-17Boston Scientific Clik X Anchor recalled for sterility assurance concerns
- FDA-Device2026-06-17Boston Scientific TCN Electrodes recalled for substandard performance
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