GLIDESHEATH 40-2560Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH Basic 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 00389701011103), received between Jun 15, 2021 and Jun 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Twisted/Bent1
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.
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 ↗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 ↗
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- 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.
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