GLIDESHEATH 40-1660Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH Basic Hydrophilic Coated Introducer Sheath · Class 2
Data updated Oct 13, 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 00389701011073), received between Mar 21, 2019 and Mar 21, 2019 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2019Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEY USED A GLIDESHEATH SLENDER 6FR 16CM FOR RADIAL ACCESS. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. THE PATIENT WAS IN GOOD CONDITION AND THE PROCEDURE WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED MARCH 13, 2019: THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED WAS A CARDIAC CATHETERIZATION. THE GLIDESHEATH HAD BLEEDING AT THE HUB. THE GLIDESHEATH WAS USED ON THE PATIENT. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8440220 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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