EndoMAXX® 00884450442234Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 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 00884450442234), 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 18, 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 A 4CM LONG BENIGN REFRACTORY STRICTURE AT 28 CM FROM THE INCISORS. AFTER MULTIPLE DILATATIONS THE ESOPHAGEAL STENT WAS SUTURED IN PLACE USING AN ENDOSCOPIC STITCHING DEVICE. THE STENT WAS IN PLACE FOR 6 WEEKS WITHOUT COMPLICATIONS WHEN THE PATIENT PRESENTED WITH FOOD AND PILL IMPACTION. THE IMPACTION WAS REMOVED, AND STENT WAS LEFT IN PLACE. SEVEN TO EIGHT WEEKS LATER THE PATIENT PRESENTED WITH HYPERTENSION AND HEMATEMESIS. THE PHYSICIAN STATES THAT WITHIN SIX HOURS OF ARRIVING AT THE HOSPITAL THE PATIENT EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510160 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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