WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
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.
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
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0394-2022