Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reported: April 30, 2025 Initiated: March 14, 2025 #Z-1641-2025
Product Description
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, 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
- 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, Spain, Thailand, Turkey, United Arab Emirates.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly. Recalled by Merit Medical Systems, Inc.. Units affected: 7453 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-1641-2025.
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