# FDA recall Z-2485-2025

> **Boston Scientific Neuromodulation Corporation** · Class II · device recall initiated 2025-06-06.

## 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.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-2485-2025
- **Recalling firm:** Boston Scientific Neuromodulation Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-06
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2025

## Citation

> AI Analytics. FDA recall Z-2485-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2485-2025. Source: US FDA. Licensed CC0.

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