# FDA recall Z-0230-2023

> **Boston Scientific Neuromodulation Corporation** · Class II · device recall initiated 2022-10-12.

## Product

Superion¿ Indirect Decompression System (IDS)    Model Numbers and Size:  101-9808 - 8mm  01-9812 - 12mm  101-9814 - 14mm

## Reason for recall

Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface.  As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

## Distribution

U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY

## Key facts

- **Recall number:** Z-0230-2023
- **Recalling firm:** Boston Scientific Neuromodulation Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-12
- **Report date:** 2022-11-23

- **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-0230-2023

## Citation

> AI Analytics. FDA recall Z-0230-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0230-2023. Source: US FDA. Licensed CC0.

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