LacriCATH LDC315TRecalls & reported problems
Quest Medical Inc · LacriCATH Lacrimal Duct Balloon Catheter, 3 mm. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10634624810195), received between Apr 10, 2017 and Apr 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Inflation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2017Inflation Problem; Device Operates Differently Than Expected
THE FACILITY MATERIALS MANAGER REPORTED AN ISSUE ENCOUNTERED BY THE PHYSICIAN WHILE USING THE LACRIMAL DUCT CATHETER. THE REPORT STATED THAT THE DEVICE WOULD NOT REMAIN INFLATED. THE REPORT STATED THAT THE CATHETER WAS REMOVED AND A SECOND ONE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6475986 ↗
Other Lacrimal Stents And Intubation Sets devices
- LacriCATH LDC213TQuest Medical Inc · Lacrimal Stents And Intubation Sets8 reports
- STENTube Lacrimal Intubation Set LIS052Quest Medical Inc · Lacrimal Stents And Intubation Sets6 reports
- LACRIFLOW LF-R090AKaneka Corporation · Lacrimal Stents And Intubation Sets2 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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