LacriCATH LDC213TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10634624810188), received between Feb 1, 2017 and Feb 6, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2020Crack; Leak/Splash; Pressure Problem; Crack

  A COPY OF THE REPORT RECEIVED FROM THE CUSTOMER STATES THAT THE LACRIMAL EYE CATHETER DID NOT HOLD PRESSURE AND LEAKED IN SURGERY. THE ALLEGED ISSUE DID NOT RESULT IN ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678602 ↗
• MalfunctionDec 10, 2019Crack; Crack; Leak/Splash

  THE COPY OF THE MEDWATCH RECEIVED FROM THE FDA STATES THAT THERE WAS A LEAK FROM THE LACRIMAL DUCT CATHETER. A NEW SET OF CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE ALLEGED ISSUE DID NOT RESULT IN ANY PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9447308 ↗
• MalfunctionJan 19, 2018Break; Material Fragmentation

  THE PHYSICIAN REPORTED AN ISSUE ENCOUNTERED WITH THE DEVICE DURING USE. THE PHYSICIAN STATED SHE WAS USING THE DEVICE ON A CHILD AND WHEN SHE INSERTED THE CATHETER INTO THE NASOLACRIMAL DUCT, SHE COULDN'T GET IT ALL THE WAY DOWN THE DUCT. THE REPORT CONTINUED THAT SHE ATTEMPTED TO PULL IT OUT AND WHEN SHE DID, THE TIP OF THE CATHETER AND BALLOON BROKE OFF INSIDE THE PATIENT ABOUT 1.5 CM ABOVE THE TIP OF THE FIRST BLACK MARKER BAND. THE PHYSICIAN SAID THIS OCCURRED PRIOR TO INFLATION. THE PHYSICIAN SAID SHE IRRIGATED THE PATIENT, BUT BELIEVES THE FRAGMENT COULD STILL BE IN THE PATIENT'S EYE AND HAD ORDERED X-RAYS ON THE PATIENT TO CONFIRM. THE DEVICE WILL NOT RETURN FOR EVALUATION. FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT IS DOING WELL AND ARE PLANNING A CT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7205985 ↗
• MalfunctionAug 31, 2017Inflation Problem

  THE HOSPITAL MATERIALS COORDINATOR REPORTED AN ISSUE ENCOUNTERED WITH THE 2MM LACRICATH DEVICE DURING USE. THE REPORT STATED THAT DURING A PROCEDURE THE BALLOON ON THE END OF THE STENT ONCE INFLATED DID NOT HOLD AFTER INSERTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833393 ↗
• MalfunctionJul 13, 2017Leak/Splash

  THE SURGICAL CENTER MATERIALS MANAGER REPORTED AN ISSUE ENCOUNTERED WITH A LACRIMAL DUCT CATHETER DURING USE. THE REPORT STATED THE DEVICE LEAKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SEE ALSO 1649914-2017-00057 FOR FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6713215 ↗
• MalfunctionJul 13, 2017Inflation Problem

  THE SURGICAL CENTER MATERIALS MANAGER REPORTED AN ISSUE ENCOUNTERED WITH A LACRIMAL DUCT CATHETER DURING USE. THE REPORT STATED THE DEVICE WOULD NOT INFLATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713212 ↗
• MalfunctionJun 24, 2017Fluid/Blood Leak; Inflation Problem; Device Operates Differently Than Expected

  THE SURGICAL CENTER'S MATERIAL MANAGEMENT REPORTED AN ISSUE ENCOUNTERED WHILE USING THE LACRICATH LACRIMAL DUCT CATHETER. THE REPORT STATED THAT THE DEVICE MALFUNCTIONED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE CATHETER'S BALLOON. THE PHYSICIAN STATED THAT THE DEVICE LEAKED FLUID, SO HE REMOVED THE CATHETER AND COMPLETED THE PROCEDURE USING A CRAWFORD TUBE INSTEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665980 ↗
• MalfunctionFeb 1, 2017Leak/Splash

  THE CLINIC REPORTED AN ISSUE WITH A LACRIMAL DUCT CATHETER DURING A PROCEDURE. THE REPORT STATED THAT THE ALLEGED EVENT OCCURRED DURING A DACROPLASTY PROCEDURE AND WAS INSERTED INTO THE PATIENT AT THE TIME. THE REPORT STATED THAT THE BALLOON PORTION OF THE DEVICE LEAKED AND WOULD NOT MAINTAIN PRESSURE. AS A RESULT OF THE ALLEGED ISSUE, THE DEVICE WAS REMOVED AND ANOTHER ONE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6295147 ↗