EndoMAXX® 00884450442371Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450442371), received between Oct 19, 2023 and Oct 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
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.
InjuryOct 19, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THE CUSTOMER WAS DX WITH MALIGNANCY AT THE GE JUNCTION, AND A COMPETITOR'S ESOPHAGEAL STENT WAS PLACED AT ANOTHER HOSPITAL. ON WEDNESDAY, (B)(6) 2023, AN EGD WAS PERFORMED WHERE THE COMPETITOR'S STENT WAS IDENTIFIED TO HAVE MIGRATED INTO THE STOMACH. THE DISTAL ESOPHAGUS WAS STRICTURED DOWN, WHERE THEY COULD NOT PASS A PEDIATRIC EGD STOMACH TO RETRIEVE THE STENT. THE DECISION WAS MADE TO USE AN ESOPHAGEAL STENT TO OPEN THE STRICTURE AND HAVE A FOLLOW-UP EGD TO RETRIEVE THE COMPETITOR'S STENT. THE PHYSICIAN PLACED AN ESOPHAGEAL STENT AND THEN DECIDED TO TELESCOPE ANOTHER STENT OVERLAPPING 3 CMS. THEY BROUGHT PATIENT BACK ON FRIDAY (B)(6) TO PERFORM EGD TO PULL THE COMPETITORS' STENT INTO THE ESOPHAGEAL STENT AND THEN REMOVE ALL REMAINING STENTS. WHEN REMOVING THE MOST PROXIMAL STENT ALL 3 STENTS WERE STILL CONNECTED AND MOVING TOGETHER. THE PROXIMAL END BROKE OFF IN THE PATIENT. THE PHYSICIAN TRIED USING A DUAL CHANNEL SCOPE AND REMOVE USING TWO GRASPERS BUT WAS UNABLE TO. THE DECISION WAS THEN MADE TO ADMIT PATIENT AND BRING IN ENT SURGEON TO ASSIST. ON SUNDAY (B)(6), THE ENT SURGEON PERFORMED A SUSPENSION LARYNGOSCOPY AND WAS ABLE TO REMOVE THE ESOPHAGEAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17965414 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.