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U.S. Department of Health and Human Services

Class 2 Device Recall EsophyX Z Fastener Delivery Device

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 Class 2 Device Recall EsophyX Z Fastener Delivery Devicesee related information
Date Initiated by FirmMarch 14, 2025
Date PostedApril 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1640-2025
Recall Event ID 96482
510(K)NumberK240879 
Product Classification Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
ProductMerit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Code Information All Lots/ UDI: 00810275011089
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information ContactMerit Customer Service
801-253-1600
Manufacturer Reason
for Recall		Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce1655 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ODE
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