GLIDECATH CG409Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350772077), received between Dec 12, 2019 and Dec 12, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2019Break; Break
THE USER FACILITY REPORTED THAT THE DOCTOR WAS TRYING TO PULL THE CATHETER OVER A WIRE AND THE CATHETER SNAPPED IN TO MULTIPLE PIECES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: No Information
MAUDE report 9460826 ↗InjuryDec 12, 2019Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. THERE WAS NO CATHETER LEFT IN THE PATIENT AND NO FURTHER INTERVENTION WAS REQUIRED.
Patient problems: No Information
MAUDE report 9460819 ↗
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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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