Air-Charged Single Sensor Coudé Catheter CAT878Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00627825001045), received between Mar 17, 2019 and Jun 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2019Material Protrusion/Extrusion

  A LABORIE URETHRAL CATHETER WAS USED IN A PATIENT IN FRANCE AS PART OF A URODYNAMICS STUDY. A METAL FILAMENT IN THE CATHETER WAS PROTRUDING AND RESULTED IN A LESION OF THE PATIENT'S URETHRA.

  Patient problems: No Code Available

  MAUDE report 8695411 ↗
• MalfunctionMar 17, 2019Material Protrusion/Extrusion

  A LABORIE CATHETER WHICH WAS USED IN A MALE PATIENT IN (B)(6) AS PART OF A URODYNAMICS STUDY HAD A STEEL WIRE PROTRUDING FROM THE CATHETER. THE PHYSICIAN EITHER DID NOT NOTICE THE DEFECT PRIOR TO INSERTING THE CATHETER INTO THE PATIENT, OR THE DEFECT OCCURRED AFTER INSERTION INTO THE PATIENT - WE ARE UNABLE TO TELL BASED ON THE INFORMATION PROVIDED - WHICH RESULTED IN THE PATIENT'S URETHRA RECEIVING MINOR SCRATCHES UPON REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS PRODUCT MALFUNCTION; THE PATIENT WAS RELEASED AND DID NOT REQUIRE ADDITIONAL FOLLOW-UP OR TREATMENTS.

  Patient problems: Tissue Damage

  MAUDE report 8427288 ↗