EsophyX® Z+ ARecalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450848111), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Failure to Deliver
Co2 was not delivering into the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818414 ↗
Other Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) devices
- EsophyX Z+ R2007Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)1 recall1 death69 reports
- SerosaFuse® Implantable Fastener Kit R2275Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)1 recall22 reports
- EsophyX2 HD R2005Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)11 reports
- EsophyX Z R2006Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)6 reports
- MUSE Endostapler 01Medigus Ltd · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)5 reports
- SerosaFuse®Merit Medical Systems, Inc. · Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)3 reports
- MUSE Staple Cartridge 02Medigus Ltd · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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