EndoMAXX® (REF MAXX-2315)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
- 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 00884450610855), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
- Material Integrity Problem1
Patient problems
- Device Overstimulation of Tissue1
- Stenosis of the esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT A PATIENT CAME IN FOR A CHECK UP DUE TO NARROWING ESOPHAGUS TWO YEARS POST ESOPHOGEAL STENT PLACEMENT. A REVISION OF THE STENT WAS SCHEDULED. UPON REMOVING THE IMPLANTED STENT, IT WAS FOUND THAT IT HAD RUPTURED ALLOWING GRANULATION TISSUE TO GROW WITHIN. DUE TO THE PATIENT'S HISTORY OF ESOPHOGEAL CANCER, A NEW ESOPHOGEAL STENT IS REQUIRED. ADDITIONAL INFORMATION STATES THAT TREATMENT WAS NOT ABLE TO BE COMPLETED SUCCESSFULLY AND THAT FOREIGN BODY WAS INTRODUCED INTO THE PATIENT AND THAT A RETRIEVAL BASKET WAS USED TO REMOVE IT.
Patient problems: Device Overstimulation of Tissue; Stenosis of the esophagus
MAUDE report 22566363 ↗
Other PROSTHESIS, ESOPHAGEAL devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.