GLIDESHEATH SLENDER 60-1065Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701011981), received between Aug 13, 2018 and Apr 10, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER DEVICE INVOLVED STOPCOCK FELL OFF THE SHEATH AT THE END OF THE PROCEDURE. THE PHYSICIAN IMMEDIATELY USED A HEMOSTAT TO STOP BLEEDING FROM SIDE ARM AS A REPLACEMENT FOR THE LOST STOPCOCK. THE BLOOD LOSS WAS MINIMAL AND NOT A CONCERN TO THE PHYSICIAN. TOMER CONCERNED THE ENTIRE LOT MAY NOT BE SAFE AND REQUESTED REPLACEMENT OF 2 TOTAL BOXES. PATIENT WAS IN FINE CONDITION. PROCEDURE OUTCOME WAS SUCCESSFULLY. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: PROCEDURE PERFORMED WAS A RIGHT RADIAL CARDIAC CATH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16710345 ↗
• MalfunctionNov 16, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT LEAKING AT THE VALVE WITH THE GLIDE SHEATH SLENDER. THERE WERE NO ISSUES WITH THE PATIENT. THE OUTCOME HAD NO PROBLEMS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 29OCT2020. THE PROCEDURE WAS A CORONARY CATH. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10842687 ↗
• MalfunctionOct 10, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT AFTER TAKING OUT THE DILATOR OF THE SHEATH OF THE INVOLVED GLIDESEATH SLENDER, BLOOD WAS PULSATING BACK THROUGH THE VALVE AS IF THE VALVE WAS NOT THERE. THE DOCTOR KEPT HIS THUMB OVER THE VALVE SO THAT THE BLEEDING WOULD STOP. THE DOCTOR THEN PUT A WIRE IN QUICKLY TO EXCHANGE FOR A DIFFERENT SHEATH. AFTER MANIPULATING THE WIRE, THE VALVE SEEMED TO GET IN POSITION AND THE LEAKAGE STOPPED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS FINISHED. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 1, 2018. THE PROCEDURE BEING PERFORMED WAS A RADIAL LEFT HEART CATHETERIZATION. THE DOCTOR DID NOT CHANGE THE SHEATHS, HE WIGGLED IT, WHILE HE HAD THE WIRE IN, AND IT STOPPED BLEEDING (IT WAS BELIEVED THAT THE VALVE REALIGNED ITSELF). ONCE BLEEDING WAS DOWN TO TRICKLE, HE PROCEEDED WITH THE REST OF CASE. THE PATIENT WAS STABLE AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 3, 2018. AFTER MANIPULATING THE WIRE, THE VALVE SEEMED TO GET INTO POSITION, AND STOPPED THE LEAKAGE. THE INITIAL SHEATH WAS KEPT IN. WIRES, BALLOONS , AND CATHETERS WERE USED THE REST OF THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952451 ↗
• MalfunctionSep 5, 2018Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED WHEN THE DOCTOR INSERTED THE 5/6 GLIDESHEATH SLENDER IT BENT IN TWO PLACES WITH HARDLY ANY FORCE. THE DOCTOR WAS PERFORMING A PERCUTANEOUS CORONARY INTERVENTION (PCI) AND ACHIEVED RADIAL ACCESS EASILY. THE SHEATH WAS EXCHANGED FOR ANOTHER SHEATH WITH THE SAME LOT NUMBER WITHOUT ANY ISSUES. THE PROCEDURE OUTCOME WAS SUCCESSFUL AFTER THE EXCHANGE OF THE SHEATH. THE PATIENT WAS IN STABLE CONDITION, AND BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO OTHER EQUIPMENT OR DEVICES BEING USED WITH THE REPORTED PRODUCT.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7846815 ↗
• MalfunctionAug 13, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE USER INSERTED THE SHEATH INTO THE RT RADIAL ARTERY AND REMOVED THE DILATOR. THE SHEATH THEN KINKED IMMEDIATELY WHERE THE HUB AND SHEATH ARE ATTACHED AND CAUSED THE SHEATH TO FLIP UP. UNREMARKABLE ANATOMY WITH NORMAL SIZE RADIAL ARTERY. THE MD HAD TO HOLD DOWN HUB OF THE SHEATH TO BE ABLE TO DRAW BLOOD FROM THE SIDEARM. A SUTURE EYE WAS UTILIZED TO SECURE SHEATH TO SKIN AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT IS STABLE AND IN GOOD CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 8/7/2018. THERE WAS NO BLOOD LOSS REPORTED DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776279 ↗