CavaClear laser sheath 500-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132022969), received between Oct 11, 2022 and Dec 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionDec 1, 2023Material Separation; Material Separation

  A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER DUE TO THE FILTER NO LONGER INDICATED. A PHILIPS 14F CAVACLEAR LASER SHEATH WAS USED, WITH AN 18F OUTER SHEATH, DOWN THE EXTERNAL JUGULAR (EJ) TO ATTEMPT FILTER REMOVAL. DURING THE PROCEDURE, THE OUTER JACKET BUCKLED UPON FORWARD PRESSURE NEAR THE BIFURCATE HANDLE, RESULTING IN A BREACH OF THE OUTER JACKET. THE PHYSICIAN FELT HEAT FROM THE BUCKLED AREA ON HIS GLOVED HAND, BUT THERE WAS NO INJURY DETECTED. USE OF THE CAVACLEAR WAS IMMEDIATELY DISCONTINUED, AND THE PROCEDURE WAS COMPLETED WITH USE OF ENDOBRONCHIAL FORCEPS WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18248101 ↗
• MalfunctionOct 11, 2022Material Twisted/Bent; Material Twisted/Bent

  A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER. THE FILTER WAS NO LONGER NEEDED, AND REMOVING IT WOULD ELIMINATE THE NEED FOR ANTICOAGULATION. THE PHYSICIAN CHOSE A SPECTRANETICS 14F CAVACLEAR LASER SHEATH TO REMOVE THE FILTER. AS THE CAVACLEAR WAS BEING USED, EXCESSIVE PUSH/PULL FORCE WAS APPLIED BY THE PHYSICIAN. AS A RESULT, THE AREA WHERE THE DEVICE''S BIFURCATE HANDLE AND THE WORKING LENGTH MEET, BENT AT A 90 DEGREE ANGLE, EXPOSING THE FIBERS. THE PHYSICIAN DISCONTINUED USE OF THE FIRST CAVACLEAR, OBTAINED A NEW CAVACLEAR, AND THE FILTER WAS SUCCESSFULLY REMOVED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15583738 ↗