GLIDESHEATH 30-1060Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH Access 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701011233), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2020Break; Leak/Splash; Break; Leak/Splash
THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WAS USED DURING THE PROCEDURE. THEY HAD RADIAL ACCESS IN LEFT RADIAL ARTERY. AT THE END OF PROCEDURE, THE CATHETER AND WIRE WERE REMOVED. THE VALVE BROKE AND BLOOD WAS POURING OUT OF THE END OF THE SHEATH. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT'S CONDITION WAS FINE, NO INJURIES. THERE WAS NO NEGATIVE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 30NOV2020. THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC CARDIAC CATHETERIZATION. THE WIRE AND CATHETER WERE BEING REMOVED FROM THE SHEATH WHEN THE VALVE BROKE. THE PATIENT'S CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11018549 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page