Roadrunner UniGlide G56160Recalls & 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
- 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 00827002561601), received between Jul 21, 2017 and Oct 16, 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 18, 2026.
Most reported problems
Device problems
- Material Separation2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9198829 ↗InjuryJul 21, 2017Material Separation; Material Separation
IT WAS REPORTED DURING A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS USED IN AN ARTERIOVENOUS (AV) FISTULOGRAM PROCEDURE. ACCESS WAS GAINED VIA A MICROPUNCTURE SHEATH AND THE 0.018 ROADRUNNER WAS POSITIONED AND PASSED BEYOND THE EXISTING STENT. THE WIRE FOLDED BACK ON ITSELF UPON ADVANCEMENT. THE WIRE WAS THEN PULLED BACK IN AN ATTEMPT TO STRAIGHTEN THE WIRE, WHEN THE WIRE SHEARED OFF INTO THE PATIENT. THE WIRE WAS ABLE TO BE SUCCESSFULLY REMOVED USING A SNARE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER WIRE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE WIRE WAS SNARED OUT OF THE PATIENT IN AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6730895 ↗
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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