Roadrunner UniGlide G56150Recalls & reported problems
Cook Incorporated · Roadrunner UniGlide Hydrophilic Wire Guide · Class 2
All models of Roadrunner UniGlide (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002561502), received between Sep 20, 2018 and Sep 25, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation2
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2018Material Fragmentation
IT WAS REPORTED THAT THE COATING OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS FLAKING. THE WIRE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7907588 ↗MalfunctionSep 25, 2018Material Fragmentation
IT WAS REPORTED THAT THE HYDROPHILIC COATING OF SEVERAL OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES WAS FLAKING OFF, APPEARING AS WHITE SPOTS, POWDER, OR FIBERS COMING OFF OF THE WIRES. THIS REPORT IS NOT RELATED TO A SINGLE EVENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7907136 ↗MalfunctionSep 20, 2018Scratched Material; Material Split, Cut or Torn
IT WAS REPORTED THAT THE GUIDE WIRE¿S POLYMER JACKET WAS SCRATCHED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THERE WERE TEARS IN THE WIRE JACKET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7895037 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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