Roadrunner G07640Recalls & reported problems
Cook Incorporated · Roadrunner Extra Support Wire Guide · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002076402), received between Aug 23, 2018 and Nov 19, 2025 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Unraveled Material3
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
- Material Frayed1
Patient problems
- Foreign Body In Patient3
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 23597379 ↗InjuryAug 12, 2025Break; Break
AS REPORTED, DURING AN ATHERECTOMY PROCEDURE, THE TIP OF A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE BROKE OFF INSIDE OF THE PATIENT. THE WIRE WAS NOT ALTERED PRIOR TO USE. ANTEGRADE FEMORAL ACCESS WAS OBTAINED FOR A CONTRALATERAL APPROACH. THE ARTERIES WERE REPORTEDLY CALCIFIED, AND IT WAS DIFFICULT TO CROSS THE LESION. PER THE REPORTER, DURING ATHERECTOMY USING ANOTHER MANUFACTURER¿S ATHERECTOMY DEVICE, THE WIRE SHEARED OFF. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, AND THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 22787227 ↗InjuryFeb 17, 2023Break; Difficult to Remove; Unraveled Material; Break; Difficult to Remove; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 16397895 ↗InjuryJan 30, 2023Break; Material Frayed; Break; Material Frayed
AS REPORTED, DURING A VENOGRAM WITH POSSIBLE ENDOVASCULAR TREATMENT, THE TIP OF A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE SEPARATED. PERCUTANEOUS ACCESS WAS OBTAINED IN THE RIGHT POPLITEAL VEIN TO TARGET THE RIGHT COMMON FEMORAL VEIN. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE COMMON FEMORAL VEIN WAS CHRONICALLY OCCLUDED WITH TRANS-PELVIC AND ILIAC COLLATERALS. AS THE WIRE WAS USED TO ACCESS THE VEIN, THROUGH ANOTHER MANUFACTURER'S 6-FRENCH SHEATH, THE TIP OF THE WIRE BROKE OFF. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OF THE DEVICE. THE WIRE WAS NOT ALTERED PRIOR TO USE. A SNARE WAS USED TO REMOVE THE SEPARATED FRAGMENT, DELAYING COMPLETION OF THE CASE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient
MAUDE report 16265206 ↗MalfunctionNov 23, 2021Unraveled Material; Unraveled Material
AS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION PROCEDURE A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE UNRAVELED WHILE BEING REMOVED. THE WIRE GUIDE HAD BEEN ADVANCED THROUGH A CXI SUPPORT CATHETER, WHILE THE USER WAS ATTEMPTING TO CROSS THE SFA. THE USER ATTEMPTED TO REMOVE THE WIRE GUIDE WHEN IT BEGAN TO UNRAVEL. ANOTHER ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12860476 ↗MalfunctionAug 23, 2018Unraveled Material; Unraveled Material
IT WAS REPORTED, THE TIP OF THE ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE "LOOKED LIKE IT WAS STARTING TO COME APART" DURING AN ANTERIOR TIBIAL/PERONEAL ARTERY RECONSTRUCTION. THE PHYSICIAN HAD THE COMPLAINT DEVICE INSIDE A 2.6 AND 4FR (FRENCH) COAXIAL CXI SYSTEM TRYING TO CROSS THE LESION IN THE PERONEAL ARTERY. THE COMPLAINT DEVICE WAS REMOVED IN ORDER TO OBTAIN SOME IMAGES OF THE AREA AND THE TIP WAS NOTED TO BE UNRAVELING. ANOTHER ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7808702 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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