GUIDE WIRE M GM1834Recalls & 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 04987350712189), received between Aug 5, 2019 and Aug 5, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation2
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.
InjuryAug 5, 2019Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TIP OF THE O.018 GUIDEWIRE BROKE OFF IN CBD DURING AN EXCHANGE OF EQUIPMENT. THE TIP WAS LEFT IN THE PATIENT AND WAS NOT ABLE TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. THE PATIENT WAS IN STABLE CONDITION AND THEY WERE AN OUTPATIENT. THE WIRE TIP WAS ABLE TO BE LOCATED IN THE PATIENT'S CYSTIC DUCT. SURGICAL INTERVENTION WAS REPORTED TO NOT BE IMMINENT. A BILIARY EXTRACTION BALLOON CATHETER WAS ALSO USED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8859752 ↗InjuryAug 5, 2019Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TIP OF THE O.018 GUIDEWIRE BROKE OFF IN CBD DURING AN EXCHANGE OF EQUIPMENT. THE TIP WAS LEFT IN THE PATIENT AND WAS NOT ABLE TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON 24JUL2019. THE PATIENT WAS IN STABLE CONDITION AND THEY WERE AN OUTPATIENT. THE WIRE TIP WAS ABLE TO BE LOCATED IN THE PATIENT'S CYSTIC DUCT. SURGICAL INTERVENTION WAS REPORTED TO NOT BE IMMINENT. A BILIARY EXTRACTION BALLOON CATHETER WAS ALSO USED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8859748 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 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.
How reports and recalls are matched · Editorial policy · Report an error on this page