CavaClear laser sheath 500-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813132022976), received between Nov 21, 2022 and Nov 17, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE COMMENCED TO REMOVE A CORDIS OPTEASE OPTIONAL IVCF DUE TO NO LONGER INDICATED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, WHEN THE CAVACLEAR WAS BEING ROCKED BACK AND FORTH TO THE FILTER, IT WAS NOTICED THAT THE DISTAL TIP FRAYED, EXPOSING THE FIBERS (MDR #3007284006-2025-00239). A SECOND 16F CAVACLEAR WAS UTILIZED; HOWEVER, THE SAME MALFUNCTION OCCURRED (MDR #3007284006-2025-00240). THEN, A THIRD 16F CAVACLEAR WAS USED, AND EXPERIENCED THE SAME ISSUE (MDR #3007284006-2025-00241). THE PROCEDURE WAS COMPLETED MANUALLY WITH 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 23569124 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE COMMENCED TO REMOVE A CORDIS OPTEASE OPTIONAL IVCF DUE TO NO LONGER INDICATED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, WHEN THE CAVACLEAR WAS BEING ROCKED BACK AND FORTH TO THE FILTER, IT WAS NOTICED THAT THE DISTAL TIP FRAYED, EXPOSING THE FIBERS. A SECOND 16F CAVACLEAR WAS UTILIZED; HOWEVER, THE SAME MALFUNCTION OCCURRED (MDR #3007284006-2025-00240). THEN, A THIRD 16F CAVACLEAR WAS USED, AND EXPERIENCED THE SAME ISSUE (MDR #3007284006-2025-00241). THE PROCEDURE WAS COMPLETED MANUALLY WITH 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 23563189 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE COMMENCED TO REMOVE A CORDIS OPTEASE OPTIONAL IVCF DUE TO NO LONGER INDICATED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, WHEN THE CAVACLEAR WAS BEING ROCKED BACK AND FORTH TO THE FILTER, IT WAS NOTICED THAT THE DISTAL TIP FRAYED, EXPOSING THE FIBERS (B)(4). A SECOND 16F CAVACLEAR WAS UTILIZED; HOWEVER, THE SAME MALFUNCTION OCCURRED (B)(4). THEN, A THIRD 16F CAVACLEAR WAS USED, AND EXPERIENCED THE SAME ISSUE (B)(4). THE PROCEDURE WAS COMPLETED MANUALLY WITH 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 23563186 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL PROCEDURE COMMENCED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO REMOVE AN OPTIONAL IVCF DUE TO PATIENT NO LONGER NEEDING IT. DURING USE, THE CAVACLEAR OUTER JACKET SEPARATED NEAR THE HANDLE. ALLIGATOR FORCEPS WERE USED TO COMPLETE THE PROCEDURE, WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23415797 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFERIOR VENA CAVA (IVC) FILTER REMOVAL COMMENCED BECAUSE THE PATIENT NO LONGER NEEDED THE IVC FILTER. PRIOR TO USE OF THE SPECTRANETICS 16F CAVACLEAR LASER SHEATH, OTHER MODALITIES WERE USED TO ATTEMPT REMOVAL, BUT UNSUCCESSFUL DUE TO THE FILTER BEING EMBEDDED TO THE IVC. THEN, THE CAVACLEAR WAS ADVANCED AND DURING USE, AN IVC PERFORATION WAS DETECTED VIA ANGIOGRAM. THEREFORE, A STENT WAS PLACED TO TREAT THE PERFORATION, WHILE ALSO SECURING THE FILTER TO THE VESSEL WALL. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE CAVACLEAR IN USE WHEN THE IVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE CAVACLEAR DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 21417198 ↗
• MalfunctionAug 6, 2024Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL PROCEDURE COMMENCED TO REMOVE A TRAPEASE PERMANENT IVCF DUE TO SYMPTOMATIC IVC OCCLUSIONS. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, A SPLIT IN THE OUTER JACKET WITH VISIBLE FIBERS WAS OBSERVED, JUST DISTAL TO THE BIFURCATE HANDLE. A NEW 16F CAVACLEAR WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19923980 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL PROCEDURE COMMENCED TO REMOVE A GREENFIELD PERMANENT ICVF, DUE TO SYMPTOMS OF BACK PAIN AND REQUEST FOR REMOVAL. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. AFTER USING THE CAVACLEAR FOR TWO CYCLES, IT WAS NOTED THAT THE BIFURCATE HANDLE WAS GENERATING HEAT, AND UPON REMOVAL, EXPOSED FIBERS WERE OBSERVED NEAR THE HANDLE. A NEW 16F CAVACLEAR WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT PATIENT OR USER HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19811715 ↗
• MalfunctionDec 8, 2022Material Twisted/Bent; Material Twisted/Bent

  A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA FILTER (IVCF) DUE TO CAVAL OCCLUSION, LEG SWELLING, AND PAIN. THE PHYSICIAN CHOSE A SPECTRANETICS 16F CAVACLEAR LASER SHEATH TO REMOVE THE FILTER. WHEN THE PHYSICIAN WAS USING THE CAVACLEAR, HE TORQUED THE DEVICE (TWISTED THE DEVICE BACK AND FORTH) IN ATTEMPT TO REMOVE THE IVCF. AFTERWARD, HE NOTICED THE CAVACLEAR'S BIFURCATE HANDLE FELT WARMER THAN NORMAL. EXAMINATION OF THE DEVICE REVEALED A PARTIAL SEPARATION ON THE WORKING LENGTH, JUST DISTAL TO THE BIFURCATE HANDLE WITH RED LIGHT EMITTING FROM THE AREA; THEREFORE, THE CAVACLEAR WAS REMOVED FROM THE PATIENT. A NEW 16F CAVACLEAR WAS USED TO SUCCESSFULLY REMOVE THE IVCF, AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15945846 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL COMMENCED BECAUSE THE PATIENT NO LONGER NEEDED THE IVCF. IT WAS NOTED THAT STRUTS OF THE IVCF HAD PREVIOUSLY PERFORATED AND WERE LOCATED OUTSIDE THE IVC. ONCE THE FILTER HAD BEEN REMOVED USING A SPECTRANETICS CAVACLEAR LASER SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. A COVERED STENT WAS USED TO SEAL OFF AN IVC PERFORATION AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE CAVACLEAR IN USE WHEN THE IVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE CAVACLEAR DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 15835621 ↗