FDA (Devices) recall action 96482
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to risks associated with device over-rotation and multiple fastener deployment.