GLIDESHEATH 20-2565Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH SS Kit Hydrophilic Coated Introducer Sheath · Class 2
All models of GLIDESHEATH (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701011189), received between Sep 22, 2021 and Sep 22, 2021 — classified as 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
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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