GLIDECATH RF*WA25110MRecalls & reported problems
Terumo Corporation · GLIDECATH XP · 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 04987350767516), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2024Material Deformation; Material Deformation
THE USER FACILITY REPORTED DURING A DIAGNOSTIC PANANGIOGRAPHY, THE GLIDE CATH XP CATHETER DEVICE WAS USED, THROUGH RADIAL ACCESS. DURING THE PROCEDURE, AFTER OBTAINING IMAGES THE CATHETER DOES NOT RESPOND TO TORQUE WHEN MANIPULATING. TWO KINKS WERE OBSERVED (DISTAL AND PROXIMAL IN THE CATHETER). HYDROPHILIC GUIDE WAS ADVANCED TO BE ABLE TO REMOVE THE CATHETER, WHICH DEFORMED. THE PAIN DURING CATHETER REMOVAL IN THE RIGHT ARM REQUIRES ANESTHESIA ASSISTANCE FOR SEDATION. THERE WERE NO ADDITIONAL COMPLICATIONS. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF THE PRODUCT AND WAS TREATED WITH ANESTHESIA. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS HARMED; HOWEVER, NOT SERIOUSLY.
Patient problems: Pain
MAUDE report 19749537 ↗
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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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