Roadrunner G06866Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide The Firm LT · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Cook Medical Roadrunner The Firm LT is a hydrophilic wire guide used to help steer catheters into place during procedures. The 29 reports mostly describe packaging and cleanliness issues found during storage or distribution — units arriving contaminated, torn packaging, frayed coating material, and one broken device — with no patient involvement described in any of them. There are no deaths and no injuries. One recall, started in August 2022 and still open, covers lots where the packaging seal was breached, so sterility may be compromised.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002068667), received between Sep 26, 2018 and Dec 5, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (19 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1840-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping19
- Tear, Rip or Hole in Device Packaging4
- Contamination /Decontamination Problem2
- Unraveled Material2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Damaged Prior to Use1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 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 23729701 ↗MalfunctionNov 21, 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 23622086 ↗MalfunctionNov 21, 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 23622042 ↗MalfunctionNov 21, 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 23622009 ↗MalfunctionNov 21, 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 23621917 ↗MalfunctionNov 21, 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 23619388 ↗MalfunctionNov 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, TWO UNITS OF THE ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE WERE "NOT CLEAN". THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597912 ↗MalfunctionNov 18, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
AS REPORTED, THE PACKAGING OF TWO UNITS OF 'ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE' ARE BROKEN. THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23581697 ↗MalfunctionJul 17, 2025Unraveled Material; Unraveled Material
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE WAS FOUND TO BE UNRAVELED PRIOR TO OPENING THE DEVICE PACKAGE. ANOTHER WIRE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 22531775 ↗MalfunctionMar 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY THE DISTRIBUTOR, A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE PRESENTED WITH A FOREIGN BODY RESEMBLING AN EYELASH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21558329 ↗MalfunctionMar 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY A DISTRIBUTOR, FOREIGN MATTER RESEMBLING AN EYELASH WAS NOTED IN A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE'S STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525738 ↗MalfunctionFeb 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY A DISTRIBUTION FACILITY, FOREIGN MATTER WAS NOTED IN A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE'S STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21452926 ↗MalfunctionFeb 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN TWO ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE PACKAGES. THIS WAS DISCOVERED WITHIN A DISTRIBUTION FACILITY; THEREFORE, THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425996 ↗MalfunctionMay 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY A DISTRIBUTOR, FOREIGN MATTER WAS FOUND INSIDE THE PACKAGE OF A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE. THERE IS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271631 ↗MalfunctionNov 8, 2023Contamination /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 18092675 ↗MalfunctionSep 12, 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 17728841 ↗MalfunctionSep 12, 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 17728836 ↗MalfunctionSep 12, 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 17728803 ↗MalfunctionSep 12, 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 17728714 ↗MalfunctionSep 7, 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 17698252 ↗MalfunctionSep 7, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 17698193 ↗MalfunctionAug 22, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17598676 ↗MalfunctionAug 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, FOREIGN MATTER WAS FOUND IN THE PACKAGING OF A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE AT THE DISTRIBUTION FACILITY. THERE WAS NO PATIENT/PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17450592 ↗MalfunctionApr 24, 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 16796921 ↗MalfunctionMar 30, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 16644961 ↗
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.