GLIDESHEATH SLENDER 60-1060Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH SLENDER Access Kit · Class 2
All models of GLIDESHEATH SLENDER (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Terumo GlideSheath Slender introducer kit has 120 adverse event reports, with 9 injuries and no deaths. Many reports describe leaks, material deformation and product quality problems, and some say the wire would not fit through the dilator. Reports rose from 1 in the prior 12 months to 66 in the last 12 months. 1 recall is open, from June 2026, after the kit was packaged with the wrong size guidewire.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00389701011974), received between Aug 22, 2018 and Jul 17, 2026 — classified as 9 injuries, 98 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (53 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Jun 15, 2026Class IIOpen, Classified
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Z-2930-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Product Quality Problem53
- Leak/Splash28
- Material Deformation12
- Difficult to Advance2
- Material Separation2
- Separation Problem2
- Activation, Positioning or Separation Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Blood Loss26
- No Consequences Or Impact To Patient13
- Insufficient Information5
- Hematoma2
- No Code Available2
- No Information2
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25857629 ↗MalfunctionJul 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855962 ↗MalfunctionJul 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855960 ↗MalfunctionJul 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855948 ↗MalfunctionJul 13, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25796468 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791687 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791686 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791684 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791671 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791670 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791668 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791427 ↗MalfunctionJul 12, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791426 ↗MalfunctionJul 10, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781911 ↗MalfunctionJul 10, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781639 ↗MalfunctionJul 10, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780522 ↗MalfunctionJul 9, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25767973 ↗MalfunctionJul 9, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766982 ↗MalfunctionJul 9, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766193 ↗MalfunctionJul 9, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765881 ↗MalfunctionJul 9, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763293 ↗MalfunctionJul 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749576 ↗MalfunctionJul 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749566 ↗MalfunctionJul 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749565 ↗MalfunctionJul 4, 2026Product Quality Problem
TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION. THE GUIDEWIRE WOULD NOT PASS THROUGH THE INNER DILATOR. THE EVENT OCCURRED PRE-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 25710825 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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