GLIDECATH CG508Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDECATH · Class 2
Data updated Oct 13, 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 04987350772473), received between Oct 26, 2017 and Oct 26, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance” (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
- Physical Resistance1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2017Physical Resistance; Physical Resistance
THE USER FACILITY REPORTED THAT THE 20 X 39 MMM CX WAS PASSED THROUGH A 5FR 100 GLIDECATH DURING A TYPE 2 ENDOLEAK THAT WAS BEING TREATED THROUGH TRANSCAVAL ACCESS. THE COIL WAS BEING FED THROUGH THE CATHETER AND RESISTANCE WAS FELT. MOST OF THE COIL WAS OUT OF THE CATHETER UNTIL THEY COULD NO LONGER PUSH THE COIL OR RETRACT IT. THE PHYSICIANS TRIED TO PUSH THE COIL OUT WITH MULTIPLE WIRES AND WERE UNSUCCESSFUL. THE CATHETER WAS THEN REMOVED AND A SNARE WAS USED TO PULL THE COIL OUT - WHICH PART OF THE COIL APPEARED TO HAVE MADE IT OUT OF THE AORTIC SAC INTO THE VENA CAVA. THE PATIENT WAS FINE AND ALREADY HAD A COIL DEPLOYED INTO THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 10/4/2017. THE GLIDECATH APPEARED TO HAVE BACKED UP AND LOOPED A LITTLE BIT WHICH MAY HAVE BEEN STRAIN FROM THE SHEATH BUT THERE WAS NO CONFIRMED KINK. NO SUBSEQUENT COILS WERE DELIVERED AS THE ENTIRE SYSTEM HAD TO BE REMOVED. THE COIL APPEARED FRAYED AND WHEN IT WAS PULLED OUT BY SNARE IT WAS VISIBLY DAMAGED.
Patient problems: Foreign Body In Patient
MAUDE report 6979351 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page