GLIDESHEATH SLENDER 80-1065Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00389701012070), received between Jul 10, 2019 and Mar 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER DEVICE WAS SUCCESSFULLY INTRODUCED INTO THE PATIENT'S RADIAL ARTERY BUT LEAKED BLOOD THROUGHOUT THE CASE FROM ONE (1) WAY VALVE. THE ESTIMATED BLOOD LOSS LESS THAN 250 CC. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 FEB 2024: PROCEDURE WAS A LEFT HEART CATHETERIZATION. THE BLOOD LEAKAGE WAS CONFIRMED TO BEING LEAKING FROM THE CC VALUE. THE ACCOUNT CONTINUED THE CASE AS IT WAS A NORMAL CATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009045 ↗
• MalfunctionFeb 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WAS INSERTED INTO RIGHT RADIAL ARTERY WITHOUT INCIDENT. A 5FR TIG CATHETER WAS INSERTED THROUGH THE SHEATH OVER A .035 J WIRE TO THE DESCENDING AORTA WITHOUT INCIDENT. THE WIRE WAS REMOVED AND SUBSEQUENT IMAGING OF BOTH RIGHT AND LEFT CORONARY ARTERIES WAS ACCOMPLISHED AGAIN WITHOUT INCIDENT. AFTER WHICH IT WAS NOTICED THAT THE SHEATH WAS LEAKING AT THE JUNCTION OF THE HUB AND THE SHEATH TUBING MATERIAL. THE LEAKING DID NOT INVOLVE THE VALVE. THE BLOOD LOSS WAS LESS THAN 10CC. THE SHEATH WAS REMOVED, AND A TR BAND WAS PLACED OVER THE PUNCTURE SITE WITHOUT INCIDENT. PATIENT CONDITION WAS REPORTED TO BE EXCELLENT, NO ISSUE. THE PROCEDURE OUTCOME WAS EXCELLENT. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 06FEB2020. THE LOCATION WAS ON THE SHEATH TUBING JUST BELOW THE VALVE/HUB AREA. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION VIA A RIGHT RADIAL APPROACH.

  Patient problems: Blood Loss

  MAUDE report 9771318 ↗
• MalfunctionSep 4, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED AN ISSUE WITH THE GLIDESHEATH SLENDER, THEY HAD TROUBLE GETTING THE SHEATH WIRE TO ADVANCE THROUGH THE SHEATH ITSELF. IT APPEARED TO HAVE A "BULB SHAPE" AT THE SOFT TIP. THEY TRIED THE DISTAL END OF THE WIRE AND IT ADVANCED WITH NO ISSUE. THE PATIENT WAS IN STABLE CONDITION. THEY WERE ABLE TO USE THE REPORTED DEVICE AND NO OTHER EQUIPMENT OR DEVICES WERE USED WITH THE REPORTED PRODUCT. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED 19AUGUST2019: THE PROCEDURE WAS A DIAGNOSTIC LEFT HEART CATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960003 ↗
• MalfunctionJul 10, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDE SHEATH SLENDER SHEATH WAS DAMAGED AND THE VALVE WAS LEAKING THROUGHOUT THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 8778211 ↗