Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Reported: April 30, 2025 Initiated: March 14, 2025 #Z-1640-2025
Product Description
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Reason for Recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 1655 units
- Distribution
- 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.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly. Recalled by Merit Medical Systems, Inc.. Units affected: 1655 units.
Why was this product recalled? ▼
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1640-2025.
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