Merit Medical recalls EsophyX Z+ with SerosaFuse Implantable Fasteners due to potential over-rotation and multiple deployment risks. Affected units include specific fastener delivery devices and cartridges.
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Merit Medical is recalling EsophyX Z+ with SerosaFuse Implantable Fasteners because of a risk of over-rotation and multiple deployment of fasteners. This could lead to complications during medical procedures.
The device can over-rotate or deploy fasteners multiple times during use, which may cause complications. This risk is related to the procedure's technical requirements and not typical use.
Patients undergoing procedures requiring these fasteners are most at risk. Medical professionals using the device for implantation may also be affected.
Check for the Merit Medical EsophyX Z+ with SerosaFuse Implantable Fasteners, including the Fastener Delivery Device and 7.5mm Cartridges. All lots and UDI numbers are listed as 00810275014011.
Verify the product name and lot numbers against the provided list: 00810275014011.
The recall addresses a potential risk of over-rotation and multiple deployment during medical procedures, but it is not described as causing serious injury in normal use.
The official recall notice does not specify a remedy or action steps beyond checking product details.
Check for the Merit Medical EsophyX Z+ with SerosaFuse Implantable Fasteners, including the Fastener Delivery Device and 7.5mm Cartridges with lot number 00810275014011.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1641-2025 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
