GLIDESHEATH SLENDER 60-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701011950), received between Jul 30, 2020 and Dec 19, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 14DEC2023: THE PROCEDURE PERFORMED WAS A CARDIAC CATHETERIZATION. THE LEAKAGE WAS UNRESOLVED. THE LEAKAGE OF BLOOD WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357996 ↗
• MalfunctionDec 19, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 14DEC2023: THE PROCEDURE PERFORMED WAS A CARDIAC CATHETERIZATION. THE LEAKAGE WAS UNRESOLVED. THE LEAKAGE OF BLOOD WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357672 ↗
• InjuryJul 30, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT AFTER GAINING BRACHIAL VEIN ACCESS AND INSERTING A CATHETER AND WIRE INTO THE IK DEVICE SHEATH THE WIRE AND CATHETER BECAME STUCK INSIDE THE SHEATH. THE WIRE, CATHETER, AND SHEATH WERE REMOVED. PRESSURE WAS HELD. ACCESS WAS OBTAINED AGAIN, AND A SECOND SHEATH INSERTED. BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS ABORTED, NOT DUE TO ACCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 09JULY2020: IT WAS A BENSON WIRE AND A BERN CATHETER. THE WIRE WAS AN .035. THE WIRE WAS IN, AND THE CATHETER WAS ADVANCED OVER THE WIRE. THERE WAS NO DIFFICULTY AT THE CROSSCUT VALVE. THE ASSUMPTION WAS EITHER THE CATHETER GOT STUCK IN THE SHEATH(MIDDLE) OR DISTAL PORTION. CATHETER, AND SHEATH WERE REMOVED, AND PRESSURE WAS HELD, THEN ACCESS WAS GAINED AGAIN AT SAME ACCESS POINT, ULTRASOUND WAS UTILIZED. NO OBSTRUCTIONS NO VISUALIZED CLOTS OR OBSTRUCTION IN THE VEIN PRIOR TO ACCESS. KINKS WERE NOT NOTED IN THE SHEATH. ANATOMY WAS NOT MENTIONED AS AN ISSUE. PROCEDURE WAS BEING PERFORMED WAS WAVELINQ FISTULA CREATION. THE SHEATH WAS USED TO DELIVER THE PRODUCT TO CREATE A FISTULA. THE PROCEDURE REQUIRES ACCESS IN VEIN AND ART

  Patient problems: Blood Loss

  MAUDE report 10344639 ↗