# FDA recall Z-0394-2022

> **Cardiovascular Systems Inc** · Class I · device recall initiated 2021-11-22.

## Product

WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

## Reason for recall

Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.

## Distribution

United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV  OUS - Netherlands

## Key facts

- **Recall number:** Z-0394-2022
- **Recalling firm:** Cardiovascular Systems Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-22
- **Report date:** 2021-12-29
- **Termination date:** 2023-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0394-2022

## Citation

> AI Analytics. FDA recall Z-0394-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0394-2022. Source: US FDA. Licensed CC0.

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