GLIDESHEATH 20-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701011134), received between May 30, 2017 and Jul 9, 2023 — classified as 1 injury, 4 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.

• MalfunctionJul 9, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE SHEATH WAS INSERTED INTO THE PATIENT'S RIGHT RADIAL ARTERY. THE SHEATH DIAPHRAGM TORE WHEN A CATHETER WAS INSERTED INTO THE SHEATH. THE PATIENT CONDITION AND PROCEDURE OUTCOME WERE NOT AFFECTED. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 23 JUN 23: THE PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION. THE DEVICE WAS EXCHANGED, AND ANOTHER TERUMO GLIDESHEATH SS 6 FRENCH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS STABLE ON TRANSFER FROM CATH LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17284958 ↗
• MalfunctionJun 24, 2023Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH KIT, SHEATH WAS OBSERVED TO BE FRAYED AND WAS DEEMED UNUSEABLE FOR THE READIAL PROCEDURE. THERE WAS NO ADVERSE PATIENT AFFECT REPORTED. THE CASE WAS DELAYED FOR TWO (2) MINUTES DUE TO OPENING A NEW ACCESS KIT. THE EVENT OCCURRED INTRA-OPERATIVE. MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196104 ↗
• InjuryMay 19, 2023Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A RADIAL LEFT HEART CATHETERIZATION WAS BEING PERFORMED. THE FELLOW HAD OBTAINED ACCESS WITH NO RESISTANCE AND THERE WAS GOOD FLOW BACK AFTER THE SHEATH WAS INSERTED. WHEN PULLING THE DILATOR, THERE WAS RESISTANCE AND THE WIRE THEN UNRAVELED. A BIT OF THE WIRE WAS LEFT IN THE PATIENT. THE PATIENT WAS THEN SEEN BY A VASCULAR SURGEON AND THE WIRE WAS LEFT ALONE FOR MEDICAL THERAPY. THE PROCEDURE WAS COMPLETED VIA A FEMORAL APPROACH. A PIECE OF THE WIRE WAS LEFT IN ARTERY WALL OF THE PATIENT. THE PATIENT WAS SEEN BY VASCULAR SURGERY; HOWEVER, THERE WAS NO SURGICAL INTERVENTION. THE PATIENT WAS IN STABLE CONDITION. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE PRODUCT INVOLVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16962969 ↗
• MalfunctionOct 3, 2019Leak/Splash; Leak/Splash

  TERUMO MEDICAL RECEIVED A VOLUNTARY HEALTH (B)(6) REPORT, MDIP REPORT NUMBER (B)(4). THE EVENT DESCRIPTION STATES: "ONE WAY VALVE ON SHEATH DEFECTIVE. BLOOD WAS LEAKING OUT OF SHEATH AND NEEDED TO BE REMOVED AND REPLACED AFTER INITIAL INSERTION FOR CARDIAC CATHETERIZATION PROCEDURE." ADDITIONAL INFORMATION WAS RECEIVED 10SEPTEMBER2019: THERE WAS NO PATIENT HARM. BLOOD LOSS WAS MINIMAL, LESS THAN 250CC'S AS THEY SWITCHED OUT THE DEVICE FOR A SECOND GLIDESHEATH SLENDER AND COMPLETED THE PROCEDURE AS INTENDED. THE PATIENT CONDITION WAS STABLE. THERE WAS NO ADDITIONAL EQUIPMENT OR OTHER DEVICES USED WITH THE REPORTED DEVICE.

  Patient problems: Blood Loss

  MAUDE report 9150452 ↗
• MalfunctionMay 30, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE WITH THE INVOLVED DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE GLIDESHEATH SLENDER PREPPED AS NORMAL AND ACCESS TO RADIAL ARTERY GAINED. GUIDEWIRE AND CATHETER ADVANCED AND DURING REMOVAL OF BLOOD IT WAS NOTED THAT BLEEDING THROUGH VALVE WAS MORE BRISK THAN NORMAL. NEXT THE CATHETER WAS ADVANCED AND WHEN REMOVED, BRISK BLEEDING WAS OBSERVED. CARDIAC CATH WAS DIAGNOSTIC AND WAS COMPLETED AT THIS POINT WITH NO ADVERSE EVENTS. THE PATIENT IS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6598040 ↗