GLIDESHEATH SLENDER 80-1670Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH SLENDER Stainless Steel Kit · 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 00389701012124), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
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.
MalfunctionFeb 17, 2023Difficult to Advance; Difficult to Advance
TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES THAT THEY WERE UNABLE TO ADVANCE THE CATHETER THROUGH THE SHEATH. THE ORIGINAL INTENDED PROCEDURE WAS A LEFT HEART CATHETERIZATION. DEVICE MALFUNCTION, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. LOCATION OF EVENT OCCURRED IN THE HOSPITALS OR. PATIENTS PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT WAS CORONARY HEART DISEASE. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JAN 2023: THE ESTIMATED BLOOD LOSS WAS 200 TO 400 ML. THE PATIENT CONDITION WAS CRITICAL BUT NOT RELATED TO THE EVENT. IMPELLED DUE TO OTHER COMPLICATIONS. IT WAS UNKNOWN IF ANY DEVICES WERE USED WITH THE INVOLVED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16394933 ↗
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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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