Merit Medical EsophyX Z+ Fastener Device Malfunction Risk Update
Merit Medical is updating instructions for the EsophyX Z+ fastener delivery device to address identified risks of device over-rotation and improper fastener deployment. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with identified malfunction risks (over-rotation and fastener deployment). No reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
Merit Medical Systems, Inc., is issuing an update to the instructions for use (IFU) for the EsophyX Z+ Fastener Delivery Device (FDA Class II). The company has identified potential risks associated with device over-rotation and multiple deployment of fasteners during use.
The recall affects 1,655 units with UDI 00810275011089. These devices 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 facility personnel should review the updated instructions for use to understand the identified risks and proper operation procedures. Users should obtain and implement the updated IFU provided by Merit Medical Systems, Inc., to ensure safe device operation.
No injuries or illnesses have been reported associated with this issue. The updated instructions are intended to prevent potential complications from improper device operation.
The recalled product
- Product
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- Hazard
- 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: 00810275011089
Distribution
Distributed nationwide across the United States.
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