GLIDESHEATHRecalls & reported problems across all models
Terumo Medical Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 12 models of GLIDESHEATH by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2016 and May 14, 2025 — classified as 6 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GLIDESHEATH problems
Device problems
- Leak/Splash18
- Break4
- Physical Resistance/Sticking3
- Unraveled Material3
- Fracture2
- Material Frayed2
- Peeled/Delaminated2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient11
- Blood Loss8
- Foreign Body In Patient5
- No Known Impact Or Consequence To Patient2
- Hematoma1
GLIDESHEATH models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GLIDESHEATH 40-1060INTRODUCER, CATHETER9 reports
- GLIDESHEATH 15-1050INTRODUCER, CATHETER5 reports
- GLIDESHEATH 20-1060INTRODUCER, CATHETER5 reports
- GLIDESHEATH 15-1060INTRODUCER, CATHETER3 reports
- GLIDESHEATH 30-2560INTRODUCER, CATHETER3 reports
- GLIDESHEATH 40-1050INTRODUCER, CATHETER2 reports
- GLIDESHEATH 40-2560INTRODUCER, CATHETER2 reports
- GLIDESHEATH 20-2565INTRODUCER, CATHETER2 reports
- GLIDESHEATH 40-1660INTRODUCER, CATHETER1 report
- GLIDESHEATH 30-1050INTRODUCER, CATHETER1 report
- GLIDESHEATH 30-1060INTRODUCER, CATHETER1 report
- GLIDESHEATH 30-2550INTRODUCER, CATHETER1 report
Recent GLIDESHEATH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Fracture; Unraveled Material; Fracture; Unraveled Material
THE USER FACILITY REPORTED THAT THE NEEDLE WAS INSERTED, BUT THE WIRE WOULD NOT TRACK, ALTHOUGH IT WAS SUSPECTED THAT THE NEEDLE WAS INSIDE THE VESSEL. THEREFORE, THE WIRE WAS PULLED OUT. AT THIS POINT, IT WAS NOTICED THAT THE WIRE WAS UNRAVELING. THE WIRE WAS SAVED, ALTHOUGH IT APPEARS THE NEEDLE WAS THROWN AWAY. THE PROCEDURE FOR THE PATIENT WAS A LEFT HEART CATHETERIZATION. THE PATIENT'S CONDITION IS STABLE, WITH NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY. NO CONCOMITANT MEDICAL PRODUCTS WERE USED WITH THE INVOLVED DEVICE. PENDING RESULTS OF A COMPUTED TOMOGRAPHY (CT) SCAN TO DETERMINE IF SUBSEQUENT ACTION IS NEEDED OR IF ALL COMPONENTS WERE REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 17 APRIL 2025: THE CT SCAN SHOWS THE FILAMENT IS IN THE BODY. IT IS LISTED AS NON-OCCLUSIVE AND APPEARS TO NOT BE IN THE ARTERY. THE PATIENT WANTS IT REMOVED, SO SCHEDULING FOR REMOVAL IS UNDERWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023001 ↗MalfunctionNov 3, 2024Break; Break
THE USER FACILITY REPORTED THAT FOLLOWING DEVICE REMOVAL OF THE GUIDEPOST AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE VALVE ON THE 6FR GLIDESHEATH WAS STUCK OPEN, RESULTING IN ARTERIAL BLOOD BEING OBSERVED AT THE END OF THE SHEATH WHERE THE VALVE IS LOCATED. MANUAL PRESSURE AND A TR BAND WERE APPLIED, AND THE HEMATOMA WAS EXPRESSED.
Patient problems: Hematoma
MAUDE report 20595800 ↗InjuryJan 13, 2024Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED ON 04MAR2024: ACCORDING TO THE PATIENTS MEDICAL RECORD THERE WAS NO FINDING SUGGESTIVE OF TORTUOUS ANATOMY. THE MICROWIRE (GUIDEWIRE) USED TO GAIN ACCESS TO THE RIGHT RADIAL ARTERY FOR THE CARDIAC CATHETERIZATION PROCEDURE WAS UNABLE TO BE REMOVED BY THE PROCEDURALIST. THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. THE ESTIMATED BLOOD LOSS WAS NOTED TO BE LESS THEN 250CC. THE RETAINED MICROWIRE WAS REMOVED DURING A SURGICAL PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INTERVENTION REQUIRED, ASIDE FROM THE DESCRIBED CUT DOWN PERFORMED TO REMOVE THE WIRE.
Patient problems: Foreign Body In Patient
MAUDE report 18509578 ↗InjuryDec 27, 2023Peeled/Delaminated; Physical Resistance/Sticking; Peeled/Delaminated; Physical Resistance/Sticking
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT NUMBER MW5147927. THE EVENT DESCRIPTION STATES THAT "UPON ACCESS TO VESSEL (HEART CATHETERIZATION), WIRE (INTRODUCER SHEATH) WAS INSERTED IN NEEDLE FROM KIT. THE WIRE WOULD NOT ADVANCE. UPON ATTEMPTED REMOVAL OF WIRE, THE WIRE WAS APPEARED SHEARED. PIECE OF WIRE NOTED UNDER FLUORO IN RIGHT WRIST. DEVICE EMBEDDED IN TISSUE OR PLAQUE."
Patient problems: Foreign Body In Patient
MAUDE report 18402214 ↗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 ↗InjuryOct 10, 2022Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT THE DOCTOR HAD A PATIENT HE WAS REVIEWING THAT HAD A RADIAL TO PERIPHERAL (R2P) PROCEDURE TEN-DAY PRIOR WHICH HAD TO HAVE OPEN SURGERY ON. THE DOCTOR STATED THAT THE PATIENT HAD TO HAVE THEIR HAND OPENED AND BLACK PIECES OF THE ACCESS WIRE THAT HAD SHEARED OFF WERE REMOVED. THE PATIENT CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 06 OCT 2022: THERE WAS MINIMAL BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL IN REMOVING THE BLACK PIECES. A 60-1050 WIRE WAS USED WITH A 80-1050 NEEDLE. THEY DID NOT USE THE A-KIT WIRE WITH THE SHEATH DESIGNED FOR THE A-KIT. THE NEEDLE SHEERED OFF THE WIRE INTO THE HAND.
Patient problems: Foreign Body In Patient
MAUDE report 15569138 ↗MalfunctionSep 22, 2021Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE PATIENT WAS STABLE AND THAT THERE WERE NO ISSUES WITH THE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021: THE VALVE WAS LEAKING DURING THE CASE. THE LEAK WAS AT THE END OF THE VALVE. THE LEAK OCCURRED DURING THE FLUSHING OF THE DEVICE. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE WAS COMPLETED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12514462 ↗MalfunctionSep 22, 2021Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE PATIENT WAS STABLE AND THAT THERE WERE NO ISSUES WITH THE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 17 SEPTEMBER 2021: THE VALVE WAS LEAKING DURING THE CASE. THE LEAK WAS AT THE END OF THE VALVE. THE LEAK OCCURRED DURING THE FLUSHING OF THE DEVICE. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE WAS COMPLETED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12514460 ↗MalfunctionJun 29, 2021Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE 6FR GLIDESHEATH LEAKED AT THE BASE OF THE CAP, ABOVE THE FLAP THAT STICKS OUT TO THE RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089820 ↗InjuryJun 24, 2021Failure to Advance; Failure to Advance
TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "DURING A CARDIAC CATHETERIZATION, THE PROCEDURALIST ATTEMPTED TO ADVANCE THE CATHETER VIA THE LEFT FEMORAL ARTERY, BUT THE AORTIC VALVE DID NOT OPEN SUFFICIENTLY TO ALLOW THE CATHETER TO ENTER FURTHER. THE CATHETER WAS REMOVED, AND INSTEAD A DIFFERENT CATHETER WAS ADVANCED TO THE ASCENDING AORTA. FOLLOWING THE CATHETERIZATION, A CURVILINEAR FOREIGN OBJECT NEAR THE LEFT FEMORAL HEAD/NECK AREA WAS SEEN ON RADIOGRAPH AND IS SUSPECTED TO BE A WIRE TIP FROM THE GLIDESHEATH GUIDEWIRE." THE ORIGINAL INTENDED PROCEDURE WAS A LEFT HEART CATHETERIZATION VIA LEFT FEMORAL ARTERY.
Patient problems: Foreign Body In Patient
MAUDE report 12056639 ↗MalfunctionJun 15, 2021Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WAS USED DURING A HEART CATHETERIZATION, AND THE SHEATH WAS FOUND TO BE DEFECTIVE. THE SHEATH HAD A BENT TIP. THE DEFECT WAS FOUND PRE-TREATMENT. THE PATIENT WAS IN FINE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12002194 ↗MalfunctionMar 5, 2021Break; Break
THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, WHEN THE GLIDESHEATH WAS OPENED FROM THE PACKAGING, THE TIP WAS SNAPPED OFF. THE OTHER FOUR IN THE BOX WERE NOT DAMAGED AND ANOTHER ONE FROM THAT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 15FEB2021. THE DILATOR TIP WAS ALREADY BROKEN WHEN THE PACKAGE WAS FIRST OPENED. THE PACKAGE WAS CAREFULLY OPENED WHEN THE SURGICAL TABLE WAS BEING SET UP FOR THE PROCEDURE. WHEN THEY NOTICED THAT THE TIP WAS BROKEN, THEY SET IT ASIDE AND GRABBED A NEW PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICES ARE STORED IN THEIR PACKAGING, HANGING ON A SHELF IN THE OPERATING ROOM. THE ROOM IS KEPT COOL AND DRY AND THE PRODUCTS ARE NOT JOSTLED AROUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11425690 ↗MalfunctionDec 28, 2020Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE GLILDESHEATH HAD A LEAKY VALVE. THERE WAS NOT PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6).2020. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS COMPLETED USING THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11078327 ↗
Other Terumo Medical Corporation products
All Terumo Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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