GLIDESHEATH SLENDER 80-1070Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH SLENDER Stainless Steel Kit · Class 2
All models of GLIDESHEATH SLENDER (13)
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 00389701012087), received between Feb 10, 2023 and Jun 30, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- 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 30, 2023Material Twisted/Bent
ELDERLY MALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE) AND RECENT SOB (SHORTNESS OF BREATH). PROCEDURE: HEART CATH, PCI (PERCUTANEOUS CORONARY INTERVENTION) OF LAD (LEFT ANTERIOR DESCENDING ARTERY). WHILE INSERTING THE SHEATH, IT BUCKLED AND WAS NOT ABLE TO BE USED. ANOTHER GLIDESHEATH (SLENDER 7FR) USED. NO KNOWN HARM TO PATIENT, DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, GLIDESHEATH SLENDER (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17236670 ↗MalfunctionFeb 10, 2023Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER DILATOR SHEERED THROUGH THE SHEATH. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 18 JAN 2023: NO BLOOD LOSS WAS REPORTED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 24 JAN 2023: THEY ATTEMPTED TO PLACE IN THE BILATERAL ILIAC STENTS VIA RADIAL ARTERY. IT WAS ULTIMATELY UNSUCCESSFUL VIA THE RADIAL APPROACH DUE TO A SUBCLAVIAN STENOSIS BUT WERE SUCCESSFUL IN DEPLOYING IT FEMORAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16349635 ↗
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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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