GLIDEWIRE GS3505Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE · Class 2
All models of GLIDEWIRE (30)
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 04987350773579), received between Feb 10, 2026 and Feb 10, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Peeled/Delaminated” (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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Peeled/Delaminated
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5180837. THE EVENT DESCRIPTION STATES: "DURING AN ATTEMPTED PORT-A-CATH PLACEMENT, THE COATING ON THE GLIDEWIRE SHEARED WITH A FRAGMENT OF THE COATING REMAINING IN THE PATIENT'S SUBCUTANEOUS TISSUE." ADDITIONAL INFORMATION WAS RECEIVED ON 14 JAN 2026: USER ERROR MAY BE TO BLAME AS THE GUIDEWIRE WAS THREADED THROUGH A NEEDLE. THE SHEARED FRAGMENT IS NOT CAUSING ANY ISSUES AND HAS NOT MIGRATED AS IT IS IN THE SUBCUTANEOUS TISSUE. THE ESTIMATED BLOOD LOSS WAS 5ML. THE PATIENT WAS FINE. THERE WAS NO ISSUE WITH HEMOSTASIS. ONLY A PORT-A-CATH KIT WAS USED WITH THE GLIDEWIRE.
Patient problems: Foreign Body In Patient
MAUDE report 24308708 ↗InjuryFeb 10, 2026Peeled/Delaminated
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5180837. THE EVENT DESCRIPTION STATES: "DURING AN ATTEMPTED PORT-A-CATH PLACEMENT, THE COATING ON THE GLIDEWIRE SHEARED WITH A FRAGMENT OF THE COATING REMAINING IN THE PATIENT'S SUBCUTANEOUS TISSUE." ADDITIONAL INFORMATION WAS RECEIVED ON 14 JAN 2026: USER ERROR MAY BE TO BLAME AS THE GUIDEWIRE WAS THREADED THROUGH A NEEDLE. THE SHEARED FRAGMENT IS NOT CAUSING ANY ISSUES AND HAS NOT MIGRATED AS IT IS IN THE SUBCUTANEOUS TISSUE. THE ESTIMATED BLOOD LOSS WAS 5ML. THE PATIENT WAS FINE. THERE WAS NO ISSUE WITH HEMOSTASIS. ONLY A PORT-A-CATH KIT WAS USED WITH THE GLIDEWIRE.
Patient problems: Foreign Body In Patient
MAUDE report 24308707 ↗
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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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