Roadrunner G08801Recalls & reported problems
Cook Incorporated · Roadrunner Extra Support Wire Guide · Class 2
All models of Roadrunner (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002088016), received between Feb 16, 2017 and Jan 13, 2025 — classified as 3 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material5
- Material Separation3
- Break2
- Device Contaminated During Manufacture or Shipping2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2025Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING ATHERECTOMY AND THROMBECTOMY OF THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS, A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE SEPARATED AT THE TIP UPON REMOVAL OF ANOTHER MANUFACTURER¿S ATHERECTOMY DEVICE. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR METAL INSTRUMENT DURING THE PROCEDURE. UPON REMOVAL OF THE OTHER MANUFACTURER¿S ATHERECTOMY DEVICE, THE TIP OF THE WIRE SEPARATED AND BECAME STUCK WITHIN AN UNKNOWN ¿UP AND OVER¿ SHEATH. THE SHEATH WAS REMOVED WITH THE WIRE FRAGMENT INSIDE, AND A NEW SHEATH WAS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143620 ↗MalfunctionMar 12, 2024Device 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 18888111 ↗MalfunctionMay 10, 2023Unraveled Material; Unraveled Material
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 16901469 ↗MalfunctionMar 22, 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 16592291 ↗MalfunctionAug 27, 2021Break; Break
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12377674 ↗MalfunctionJul 27, 2021Unraveled Material; Unraveled Material
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 12232826 ↗MalfunctionApr 26, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723233 ↗MalfunctionJan 19, 2021Unraveled Material; Unraveled Material
AS REPORTED, AT THE END OF A PROCEDURE INVOLVING AN ANGIOGRAM, ANGIOPLASTY, AND ATHERECTOMY OF THE RIGHT LEG, A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE UNRAVELED UPON REMOVAL OF THE DEVICE. THE WIRE WAS REMOVED IN IT'S ENTIRETY. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11196176 ↗MalfunctionSep 15, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10535689 ↗InjuryJun 26, 2020Material 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 Code Available
MAUDE report 10201916 ↗MalfunctionOct 5, 2018Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7938403 ↗InjuryJan 11, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN LEFT LOWER EXTREMITY (LLE) ANGIOGRAM, THE 0.014 INCH DIAMETER ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS ADVANCED TO THE LEFT PERONEAL ARTERY. ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE WAS ADVANCED OVER THE WIRE GUIDE TO THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA)/ TIBIOPERONEAL TRUNK AND USED TO REDUCE THE PLAQUE BURDEN. AS THE ATHERECTOMY DEVICE WAS REMOVED AND THE WIRE GUIDE WAS ADVANCED THEN PULLED BACK, IT WAS OBSERVED THAT APPROXIMATELY 1 TO 2 MILLIMETERS (MM) OF THE TIP OF THE WIRE HAD SHEERED OFF AND LODGED IN A SMALL SIDE BRANCH OF THE PERONEAL ARTERY. THE SMALL PORTION OF THE WIRE TIP REMAINED INSIDE OF THE PATIENT'S ANATOMY. 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: Device Embedded In Tissue or Plaque
MAUDE report 7183664 ↗InjuryFeb 16, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING A LEG ANGIO, THE WIRE BROKE OFF IN THE PATIENT WHEN ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE WAS PASSED OVER THE ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE. THE PIECE OF THE WIRE WAS LEFT IN THE OCCLUDED ARTERY AS "ENDO TRASH". BECAUSE THE ARTERY WAS TOTALLY OCCLUDED, THERE WAS NO CONCERN FOR EMBOLIZATION. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6335378 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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