Roadrunner UniGlide G56173Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002561731), received between Apr 3, 2018 and Jul 18, 2024 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Flaked” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jul 19, 2022Class IIOpen, Classified
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Z-1713-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Flaked2
- Contamination /Decontamination Problem1
- Defective Device1
- Device Contaminated During Manufacture or Shipping1
- Material Separation1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- No Code Available1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2024Flaked; Flaked
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19777767 ↗MalfunctionDec 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18351354 ↗MalfunctionAug 22, 2023Flaked; Flaked
AS ORIGINALLY REPORTED, THE LUBRICITY OF THREE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES WAS INSUFFICIENT, MAKING THE WIRES DIFFICULT TO ADVANCE THROUGH CATHETERS AFTER MULTIPLE SALINE FLUSHES. THE WIRES WERE NOT ALTERED PRIOR TO USE. THE WIRES WERE FLUSHED AND WIPED DOWN WITH NORMAL SALINE TO ACTIVATE THE HYDROPHILIC COATING AND WERE KEPT HYDRATED IN A BOWL WHEN NOT IN USE. THE WIRES WERE USED NO MORE THAN TWO TIMES EACH. LATEX-FREE GLOVES WERE WORN. PER THE CUSTOMER, NO FLAKING WAS NOTED ON ANY OF THE WIRES. NOTHING WAS LEFT IN THE PATIENT, NO ADDITIONAL PROCEDURES WERE NEEDED, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND EVALUATION OF UNUSED DEVICES FROM THE CUSTOMER (FROM THE SAME LOT), FLAKING OF THE HYDROPHILIC COATING WAS NOTED ONE UNUSED/PRIOR-TO USE WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597076 ↗InjuryJun 3, 2021Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED 21JUL2021. ANOTHER MANUFACTURER'S ENTRY NEEDLE WAS USED FOR ACCESS AND THE COMPLAINT WIRE WAS REMOVED THROUGH THE ENTRY NEEDLE. LATEX GLOVES WERE WORN, AND THE HYDROPHILIC COATING WAS ACTIVATED USING SALINE. THE DEVICE, WHICH WAS ONLY USED ONE TIME, WAS KEPT HYDRATED WHEN NOT IN USE.
Patient problems: Foreign Body In Patient
MAUDE report 11929910 ↗MalfunctionJan 21, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9611248 ↗MalfunctionSep 18, 2018Defective Device
THE COMPLAINANT REPORTED THAT THE HYDROPHILIC WIRE DISTAL TIP WAS UNEVENLY COATED. THE PRODUCT WAS NOT USED, AND THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE PRODUCT ISSUE. IT WAS FURTHER NOTED THAT THE POLYMER MATERIAL LOCATED AT THE DISTAL TIP WAS PARTIALLY ELONGATED, GIVING THE APPEARANCE OF A DISTORTED DISTAL TIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7886213 ↗InjuryApr 3, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING A FISTULAGRAM ON (B)(6) 2018, THE TIP OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE SHEARED OFF AND WAS RETAINED IN THE PATIENT. THE PATIENT WAS BROUGHT BACK ON (B)(6) 2018 FOR A SURGICAL FOREIGN BODY RETRIEVAL OF WIRE FRAGMENT FROM THE LEFT VENTRICLE AND PULMONARY OUTFLOW TRACK. THE TIP OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS SAFELY REMOVED. NO OTHER INTERVENTIONS WERE REQUIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 7393421 ↗
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 · each recall links to the FDA recall notice
- 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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