FDA-Device2025-04-30Class II
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical Systems, Inc.
Hazard
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Sold states
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.
Affected count
1655 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2025Don't want to check this manually?
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