Recall Z-1641-2025 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Merit Medical Systems, Inc.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
| Date | Apr 21, 2025 (initiated Mar 14, 2025) |
| Status | Open, Classified |
| Reason | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| Root cause | Under Investigation by firm |
| Action | 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 t |
| Quantity | 7453 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories Endogastric Solutions, Inc., Apr 26, 2024 |