—#213016

Product

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

FDA product code: ODE — Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K240879
Affected lot / code info: All Lots/ UDI: 00810275011089

Why it was recalled

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On March 14, 2025, Merit Medical issued a "Urgent Medical Device Recall Notice via E-Mail, followed by mail to affected consignees. Merit asked consignees to take the following actions: 1. Read and understand this communication and the updated IFU referenced in the attached poster. 2. There is no need to return product to Merit. 3. Post the attached poster on or near the affected products so users are aware of the updated IFU. 4. Discard the current IFU with the product at point of use. 5. Ensure that applicable personnel within your organization are made aware of this communication. 6. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 7. If you require paper IFUs, please contact RESPONSE@merit.com. 8. Please acknowledging you are aware of the information communicated and have completed the actions required of you. 9. If you require additional product training regarding the IFU updates, please contact your Merit Sales Representative to schedule.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-03-14
Posted by FDA: 2025-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.