Merit Medical EsophyX Z+ Fastener Delivery Device Safety Update
Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to 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 with an updated instruction manual to address identified risks. The source text does not report any illnesses or injuries, and the hazard is mitigated through information/instruction updates rather than product removal, consistent with a Moderate severity classification.
Plain-English summary
Merit Medical Systems, Inc. is issuing an update to the instructions for use (IFU) for the Merit Medical EsophyX Z+ Fastener Delivery Device (REF: R2007, UDI: 00810275011089). The update addresses identified risks related to device over-rotation and multiple deployment of fasteners during use.
Approximately 1,655 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. The device is prescription-only and supplied sterile.
Healthcare providers and patients using this device should consult the updated instructions for use provided by Merit Medical Systems, Inc. for guidance on proper device handling and deployment to mitigate the identified risks.
The recalled product
- Product
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- device-over-rotation
- fastener-deployment-risk
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: 00810275011089
Distribution
Distributed nationwide across the United States.
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