Merit Medical EsophyX Z+ Fastener Delivery Device Instructions Update
Merit Medical has updated instructions for the EsophyX Z+ fastener delivery device to provide additional information about risks associated with device over-rotation and multiple fastener deployment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an instructional update for a medical device. The source text does not report any illnesses, injuries, or deaths, and the hazard is addressed through updated labeling and instructions rather than a physical device defect. Per the rubric, this constitutes a moderate severity recall.
Plain-English summary
Merit Medical Systems, Inc. has issued an update to the instructions for use (IFU) for the EsophyX Z+ with SerosaFuse Implantable Fasteners system. The update provides additional information related to risks with device over-rotation and multiple deployment of fasteners.
The affected product is the Merit Medical REF: R2275 EsophyX Z+ system, which includes a fastener delivery device and 7.5mm cartridges. Approximately 7,453 units have been distributed worldwide, including throughout the United States and to Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, and the United Arab Emirates.
Healthcare providers and facilities using this device should review the updated instructions for use to understand the risks associated with over-rotation and multiple fastener deployment.
The recalled product
- Product
- Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- device-over-rotation
- fastener-deployment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI: 00810275014011
Distribution
Distributed nationwide across the United States.
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