GLIDEWIRE GR3513Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987350778376), received between Jan 8, 2019 and Nov 30, 2023 — classified as 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated4
- Break2
- Material Separation2
Patient problems
- Foreign Body In Patient6
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2023Break; Break
THE USER FACILITY REPORTED THAT THE GLIDEWIRE BROKE DURING A PROCEDURE. IT WAS REFERENCED THAT IT HAD NOT BEEN LEFT IN THE PATIENT. THE EVENT OCCURRED INTRA-OPERATIVE.
Patient problems: Insufficient Information
MAUDE report 18235992 ↗InjuryFeb 23, 2023Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT DURING A PACEMAKER INSERTION CASE, THE SURGEON USED TWO GLIDEWIRES DURING THE PROCEDURE. BOTH GLIDEWIRES GOT STUCK INSIDE THE PATIENT. UPON REMOVAL, THE COATING WAS NOTED TO BE BROKEN AND PEELED AWAY FROM BOTH THE WIRES. THE SURGEON WAS NOTIFIED TH SCRUB NURSE, CHARGE NURSE AND ORDERING PERSONNEL.
Patient problems: Foreign Body In Patient
MAUDE report 16427689 ↗InjuryFeb 23, 2023Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT DURING A PACEMAKER INSERTION CASE, THE SURGEON USED TWO GLIDEWIRES DURING THE PROCEDURE. BOTH GLIDEWIRES GOT STUCK INSIDE THE PATIENT. UPON REMOVAL, THE COATING WAS NOTED TO BE BROKEN AND PEELED AWAY FROM BOTH THE WIRES. THE SURGEON WAS NOTIFIED TH SCRUB NURSE, CHARGE NURSE AND ORDERING PERSONNEL.
Patient problems: Foreign Body In Patient
MAUDE report 16427680 ↗InjuryFeb 23, 2023Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT DURING A PACEMAKER INSERTION CASE, THE SURGEON USED TWO GLIDEWIRES DURING THE PROCEDURE. BOTH GLIDEWIRES GOT STUCK INSIDE THE PATIENT. UPON REMOVAL, THE COATING WAS NOTED TO BE BROKEN AND PEELED AWAY FROM BOTH THE WIRES. THE SURGEON WAS NOTIFIED TH SCRUB NURSE, CHARGE NURSE AND ORDERING PERSONNEL.
Patient problems: Foreign Body In Patient
MAUDE report 16427673 ↗InjuryFeb 23, 2023Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT DURING A PACEMAKER INSERTION CASE, THE SURGEON USED TWO GLIDEWIRES DURING THE PROCEDURE. BOTH GLIDEWIRES GOT STUCK INSIDE THE PATIENT. UPON REMOVAL, THE COATING WAS NOTED TO BE BROKEN AND PEELED AWAY FROM BOTH THE WIRES. THE SURGEON WAS NOTIFIED BY THE SCRUB NURSE, CHARGE NURSE AND ORDERING PERSONNEL.
Patient problems: Foreign Body In Patient
MAUDE report 16427667 ↗InjuryJun 18, 2021Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS USED DURING THE PROCEDURE; THE DOCTOR REMOVED THE WIRE AND A PIECE OF THE COATING WAS MISSING. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 24MAY2021. THE TYPE OF PROCEDURE BEING PERFORMED WAS A PM. IT WAS UNKNOWN WHERE ON THE WIRE THAT THE COATING WAS MISSING. FLUOROSCOPY WAS PERFORMED AND CONFIRMED THE MISSING PIECE OF THE COATING WAS LEFT IN THE PATIENT. THE ESTIMATED BLOOD LOSS WAS GREATER THAN 25 ML. ADDITIONAL INFORMATION WAS RECEIVED ON 25MAY2021. THE MISSING PIECE WAS NOT REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 12024907 ↗InjuryMay 10, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 24MAY2021. THE TYPE OF PROCEDURE BEING PERFORMED WAS A PM. IT WAS UNKNOWN WHERE ON THE WIRE THAT THE COATING WAS MISSING. FLUOROSCOPY WAS PERFORMED AND CONFIRMED THE MISSING PIECE OF THE COATING WAS LEFT IN THE PATIENT. THE ESTIMATED BLOOD LOSS WAS GREATER THAN 25 ML. ADDITIONAL INFORMATION WAS RECEIVED ON 25MAY2021. THE MISSING PIECE WAS NOT REMOVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11796624 ↗MalfunctionJan 8, 2019Break; Break
A USER FACILITY MEDWATCH (B)(4) WAS RECEIVED BY TERUMO ON DECEMBER 20, 2018 AND REPORTED THE FOLLOWING: THE USER FACILITY REPORTED THAT THE RADIFOCUS GLIDEWIRE UNCOILED WHILE THE PATIENT WAS IN THE OPERATING ROOM FOR A PACER WIRE INSERTION. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8228096 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.