Lumiflex 00718018WRecalls & reported problems
US Endoscopy · LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0 cm-18mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995244712), received between May 22, 2026 and May 22, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove3
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Difficult to Remove
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LUMIFLEX BALLOON DILATION CATHETER WAS DEFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY AFTER USER FACILITY PERSONNEL REMOVED THE SCOPE AND BALLOON TOGETHER AND CUT THE CATHETER TO ALLOW IT TO BE FULLY EXTRACTED FROM THE WORKING CHANNEL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25258921 ↗MalfunctionMay 22, 2026Deflation Problem; Difficult to Remove
THE USER FACILITY REPORTED THAT DURING TWO PATIENT PROCEDURES INVOLVING THE USE OF THEIR LUMIFLEX BALLOON DILATION CATHETER, THERE WERE ISSUES WITH BALLOON DEFLATION THAT RESULTED IN PROCEDURAL DELAYS. DURING THESE PROCEDURES, THE CATHETERS COULD NOT BE REMOVED FROM THE SCOPES, REQUIRING USER FACILITY PERSONNEL TO REMOVE THE SCOPE AND BALLOON TOGETHER. IN ONE OF THE PROCEDURES, ALTHOUGH THE BALLOON WAS SUCCESSFULLY DEFLATED, THE SCOPE AND BALLOON STILL HAD TO BE REMOVED TOGETHER BECAUSE THE BALLOON COULD NOT BE SEPARATED FROM THE SCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257645 ↗MalfunctionMay 22, 2026Difficult to Remove
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR LUMIFLEX BALLOON DILATION CATHETER WAS DEFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY AFTER USER FACILITY PERSONNEL REMOVED THE SCOPE AND BALLOON TOGETHER AND CUT THE CATHETER TO ALLOW IT TO BE FULLY EXTRACTED FROM THE WORKING CHANNEL. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257157 ↗
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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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