FDA Medical devices recall ·
Superion IDS Kit Superion Indirect Decompression System 8MM… recall
- Recall number
- Z-2485-2025
- Date
- (initiated June 6, 2025)
- Company / brand
- Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop, Valencia, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 70,516
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.
Why was it recalled?
As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632 40117221 40113198 40113255 40113385 40113391 40113482 40106856 40027385 26176977 800276 800301 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 ALL Lot/Batch Numbers: 40222297 40213592 40199967 40198809 40195249 40186649 40181505 40166300 40157622 40141657 40141770 40136859 40131798 40132036 40112806 40106870 40093564 40080016 40080111 40076497 40070306 40070307 40052009 40045101 40034339 40027338 40027364 40022398 40018296 40018338 40010128 40004038 40004068 40000647 30244690 30178729 29985230 29849515 29849969 29668712 29668713 29578948 29578949 29360265 29360263 29360264 29160559 29160625 28756501 28627193 28627192 28627194 28501592 28501591 28501593 28344375 28344376 28344377 28133122 800279 800345 800269 800278 800268 800280 800261 800270 700089 800259 800260 800258 800250 800317 800318 700085 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 ALL Lot/Batch Numbers: 40280071 40245960 40222355 40211234 40211404 40211463 40199117 40199211 40186760 40165937 40157506 40157279 40139759 40140041 40132011 40129328 40114193 40114290 40106757 40106924 40093299 40093565 40080015 40080124 40070323 40051777 40045673 40045706 40044635 40045080 40027314 40027337 40027346 40018297 40018311 40018344 40018360 40010112 40010126 40010144 40004051 40004081 40003228 40000665 30244396 30244397 29985232 29985233 29927
Distribution
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2485-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.