Roadrunner UniGlide G30496Recalls & 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 00827002304963), received between Sep 26, 2018 and Sep 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging2
- Break1
- Material Fragmentation1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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 15, 2023Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, WHILE PREPARING FOR AN UNKNOWN PROCEDURE, THE STERILE BARRIER OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S PACKAGE WAS FOUND TO BE DAMAGED/COMPROMISED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17756464 ↗MalfunctionAug 17, 2022Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, PRIOR TO USE DURING AN UNKNOWN PROCEDURE, A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S PACKAGE WAS FOUND TO BE DAMAGED. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, PART OF THE SEAL ON THE SIDE OF THE PACKAGE WAS OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15243343 ↗MalfunctionSep 26, 2018Break; Material Fragmentation; Structural Problem
IT WAS REPORTED THAT THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS EASILY LOSING THE CURVE AT ITS TIP, AND ITS COATING WAS FLAKING. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7911284 ↗
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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