EndoMAXX® 00884450093047Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450093047), received between Sep 30, 2022 and Sep 30, 2022 — classified as 1 death.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
DeathSep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN ALLEGES THAT POST ESOPHAGEAL STENT DEPLOYMENT; A PATIENT HAD EXPIRED. THE PHYSICIAN STATES THAT THE ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED TO SEAL AN ESOPHAGEAL PERFORATION APPROXIMATELY 9 MONTHS AGO. THE PERFORATION WAS LOCATED APPROXIMATELY 20CM FROM THE INCISORS. THE ESOPHAGEAL STENT WAS SUTURED IN PLACE USING AN ENDOSCOPIC STITCHING DEVICE. THREE WEEKS LATER DURING A SCHEDULED PATIENT CHECK-UP, THE PERFORATION WAS STILL SEALED, AND THE PATIENT WAS DOING WELL. SIX TO SEVEN WEEKS LATER, THE PATIENT PRESENTED WITH HEMOPTYSIS AND HAD DEVELOPED ADDITIONAL BLEEDING COMPLICATIONS. THE PATIENT EXPIRED IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS ACQUIRED FROM THE PHYSICIAN OR THE ACCOUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510148 ↗
Other PROSTHESIS, ESOPHAGEAL devices
- WallFlex™ Esophageal M00516730Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall29 reports
- WallFlex™ Esophageal M00516740Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death22 reports
- WallFlex™ Esophageal M00516750Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death19 reports
- WallFlex™ Esophageal M00516700Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall18 reports
- WallFlex™ Esophageal M00516910Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall15 reports
- WallFlex™ Esophageal M00516930Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall14 reports
- WallFlex™ Esophageal M00516710Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall13 reports
- WallFlex™ Esophageal M00516940Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall12 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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