GUIDE WIRE M GM1832Recalls & reported problems
Terumo Corporation · RADIFOCUS GUIDE WIRE M Small Vessel Gold · Class 2
All models of GUIDE WIRE M (6)
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 04987350711922), received between Oct 21, 2019 and Oct 21, 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
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2019Break; Break
TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "DURING AORTOGRAM WITH RIGHT LOWER EXTREMITY RUNOFF, PHYSICIAN WAS USING A GLIDEWIRE GOLD AND THE TIP OF THE WIRE BECAME LODGED IN PLAQUE, IN THE PATIENTS RIGHT ANTERIOR TIBIAL ARTERY. THE TIP OF THE DEVICE BROKE OFF AND REMAINED IN THE PLAQUE. DECISION MADE TO LEAVE IN".
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9213421 ↗InjuryOct 21, 2019Break; Break
TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 3600510000-2019-8024. THE EVENT DESCRIPTION STATES: "DURING AORTOGRAM WITH RIGHT LOWER EXTREMITY RUNOFF, PHYSICIAN WAS USING A GLIDEWIRE GOLD AND THE TIP OF THE WIRE BECAME LODGED IN PLAQUE, IN THE PATIENTS RIGHT ANTERIOR TIBIAL ARTERY. THE TIP OF THE DEVICE BROKE OFF AND REMAINED IN THE PLAQUE. DECISION MADE TO LEAVE IN".
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9213420 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 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 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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