GLIDECATH CG507Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDECATH · Class 2
All models of GLIDECATH (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350772459), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 injury.
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
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2018Material Separation; Material Separation
THE USER FACILITY REPORTED THAT WHEN THE CATHETER WAS REMOVED FROM THE PATIENT THE TIP APPEARED TO BE SHEARED OFF WHEN USING THE GLIDECATH DEVICE. A FOLLOW-UP CT SCAN WAS PERFORMED AND THE TIP OF THE CATHETER WAS FOUND TO BE IN THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY). THE PATIENT WAS TRANSFERRED TO INTERVENTIONAL RADIOLOGY WHERE THE FOREIGN OBJECT WAS SUCCESSFULLY RETRIEVED. IT WAS REPORTED THAT THE PATIENT IS HEALTHY. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 7/20/18. THE PROCEDURE PERFORMED WAS A DISTAL RENAL ANGIOGRAPHY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7746686 ↗
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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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