Roadrunner G09105Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide The Firm · Class 2
Quick summary
This Cook Roadrunner PC Wire Guide is a hydrophilic-coated guide wire used to help catheters and other instruments pass through vessels. The 33 reports mostly describe packaging and surface problems — contamination, peeling or separating coating, kinks, breaks, and damaged sterile packaging — with one injury and no deaths. There have been no recalls naming this device, and reports have slowed in the past year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00827002091054), received between Jun 5, 2018 and Oct 22, 2025 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 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
- Contamination /Decontamination Problem7
- Device Contaminated During Manufacture or Shipping7
- Break3
- Device Contamination with Chemical or Other Material3
- Material Separation3
- Peeled/Delaminated3
- Structural Problem3
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Patient Involvement10
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Device 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 23361201 ↗MalfunctionSep 19, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 23JAN2026. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OF THE WIRE. LATEX SURGICAL GLOVES WERE WORN. THE COATING WAS ACTIVATED WITH A SOAKED GAUZE PAD, JUST BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT. THE WIRE, WHICH WAS USED A TOTAL OF THREE TIMES DURING THE PROCEDURE, WAS KEPT HYDRATED INSIDE A WATER BASIN WHILE NOT IN USE. THE COATING WAS REACTIVATED BEFORE REUSE. A COOK INFLATION DEVICE AND COOK INTRODUCER WERE USED DURING THE PROCEDURE. THE SEPARATED FRAGMENT REMAINED IN A CATHETER, WHICH WAS REMOVED FROM THE PATIENT. THE WIRE FRAGMENT WAS THEN REMOVED FROM THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096227 ↗MalfunctionMay 30, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS INITIALLY REPORTED THAT A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS FOUND TO BE KINKED UPON OPENING THE PACKAGE BEFORE AN UNKNOWN PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 20-MAY-2025 THE POLYMER JACKET OF THE WIRE GUIDE HAD PEELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115150 ↗MalfunctionSep 23, 2024Material Deformation; Material Deformation
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 20284148 ↗MalfunctionJul 8, 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 19691937 ↗MalfunctionMay 21, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY A DISTRIBUTOR, THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS "BROKEN". THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19364578 ↗MalfunctionMay 15, 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 19319282 ↗MalfunctionMay 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY A DISTRIBUTOR, A HOLE/TEAR WAS NOTED IN A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE'S STERILE PACKAGE. THE HOLE/TEAR WAS FOUND UPON ARRIVAL AND INSPECTION OF THE DEVICE AT THE DISTRIBUTION FACILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19319281 ↗MalfunctionMay 10, 2024Contamination /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 Clinical Signs, Symptoms or Conditions
MAUDE report 19288698 ↗MalfunctionMay 8, 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 19272820 ↗MalfunctionJan 24, 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 18574549 ↗MalfunctionJun 15, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, DURING INSPECTION IT WAS DISCOVERED THAT A PIECE OF HAIR WAS INSIDE THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE. THE DEVICE WAS NOT INVOLVED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14696935 ↗MalfunctionNov 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12771517 ↗MalfunctionOct 7, 2021Unraveled Material; Unraveled Material
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12593750 ↗MalfunctionApr 7, 2021Device 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 11628835 ↗MalfunctionJun 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Patient Involvement
MAUDE report 10107244 ↗MalfunctionApr 7, 2020Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, UPON OPENING THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE PACKAGE, PART OF THE WIRE WAS PEELING. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. 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 Consequences Or Impact To Patient
MAUDE report 9933234 ↗MalfunctionNov 27, 2019Contamination /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 9383440 ↗MalfunctionSep 9, 2019Contamination /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: Not Applicable
MAUDE report 8974232 ↗MalfunctionSep 6, 2019Contamination /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 8969459 ↗MalfunctionJul 9, 2019Contamination /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 8772741 ↗MalfunctionMay 23, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
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 8637087 ↗MalfunctionSep 25, 2018Entrapment of Device; Material Separation; Structural Problem
THE COMPLAINANT REPORTED THAT THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE COULD NOT BE REMOVED FROM THE HOLDER. IT WAS FURTHER NOTED THAT A SECTION OF THE POLYMER MATERIAL WAS MISSING FROM THE DISTAL END OF THE WIRE WHICH RESULTED IN EXPOSURE OF THE INNER MANDRIL WIRE. THIS PRODUCT ISSUE OCCURRED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED IMPACT ON THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 7906921 ↗MalfunctionSep 24, 2018Break
THE COMPLAINANT REPORTED THAT THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE BROKE WHEN IT WAS PULLED PRIOR TO PATIENT CONTACT. IT WAS FURTHER NOTED THAT A SECTION OF THE POLYMER MATERIAL WAS MISSING FROM THE DISTAL END OF THE WIRE WHICH RESULTED IN EXPOSURE OF THE INNER MANDRIL AND COIL. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901511 ↗MalfunctionSep 21, 2018Break; Component Missing; Scratched Material
THE COMPLAINANT REPORTED THAT THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE BROKE WHEN IT WAS PULLED PRIOR TO PATIENT CONTACT. IT WAS FURTHER NOTED THAT A SECTION OF THE POLYMER MATERIAL WAS MISSING FROM THE DISTAL END OF THE WIRE WHICH RESULTED IN EXPOSURE OF THE INNER MANDRIL AND COIL. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7899627 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.