GUIDE WIRE M GM1833Recalls & reported problems
Terumo Corporation · RADIFOCUS GUIDE WIRE M Small Vessel Gold · Class 2
All models of GUIDE WIRE M (6)
Data updated Oct 18, 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 04987350712165), received between Dec 28, 2021 and Dec 28, 2021 — 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 18, 2026.
Most reported problems
Device problems
- Break2
- Material Separation2
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.
InjuryDec 28, 2021Break; Material Separation; Break; Material Separation
THE USER FACILITY REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE (GW) GOLD BROKE OFF WHILE ADVANCING THE WIRE IN A CALCIFIED STENT IN THE FEMORAL ARTERY. A COOK GUIDING SHEATH AND CATHETER WERE USED TO ADVANCE THE GOLD WIRE INTO THE OCCLUSION LOCATED IN THE LUMEN OF A PREVIOUSLY IMPLANTED STENT. THE PATIENT WAS OK, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 30NOVEMBER2021. THE TIP WAS NOT REMOVED. THEY ARE BRINGING THE PATIENT BACK FOR A BYPASS SURGERY, HOWEVER, THEY FELT AS THOUGH THE TIP WAS SECURED IN THE CALCIFICATION OF THE STENT.
Patient problems: Foreign Body In Patient
MAUDE report 13095701 ↗InjuryDec 28, 2021Break; Material Separation; Break; Material Separation
THE USER FACILITY REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE (GW) GOLD BROKE OFF WHILE ADVANCING THE WIRE IN A CALCIFIED STENT IN THE FEMORAL ARTERY. A COOK GUIDING SHEATH AND CATHETER WERE USED TO ADVANCE THE GOLD WIRE INTO THE OCCLUSION LOCATED IN THE LUMEN OF A PREVIOUSLY IMPLANTED STENT. THE PATIENT WAS OK, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 30NOVEMBER2021. THE TIP WAS NOT REMOVED. THEY ARE BRINGING THE PATIENT BACK FOR A BYPASS SURGERY, HOWEVER, THEY FELT AS THOUGH THE TIP WAS SECURED IN THE CALCIFICATION OF THE STENT.
Patient problems: Foreign Body In Patient
MAUDE report 13095696 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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