Roadrunner G18153Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002181533), received between Sep 14, 2017 and Sep 2, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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-1837-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22937548 ↗
• MalfunctionJan 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE'S STERILIZED PACKAGE CONTAINED A HAIR. THE HAIR WAS FOUND WHEN THE DISTRIBUTOR RECEIVED THE DEVICE. DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178251 ↗
• MalfunctionNov 14, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS DISCOVERED TO BE BROKEN PRIOR TO PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136057 ↗
• MalfunctionSep 14, 2021Scratched Material; Scratched Material

  AS REPORTED, AFTER REMOVING A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE FROM THE PACKAGE, A SLIGHT SCRATCH ON THE COATING OF THE DEVICE WAS DISCOVERED. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467028 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS THE WHITE COATING (POLYMER JACKET) THAT PEELED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711872 ↗
• MalfunctionSep 14, 2017Flaked; Flaked

  AS REPORTED IN THE VOLUNTARY MEDWATCH REPORT RECEIVED FROM THE USER FACILITY, "DURING URETEROSCOPY PROCEDURE, WHILE REMOVING THE COOK MEDICAL ROADRUNNER HYDROPHILIC PC WIRE, THE PROTECTIVE COATING SHREDDED UPON REMOVAL THRU THE SCOPE. THERE IS A POSSIBILITY THAT THE PROVIDER CAME INTO CONTACT WITH THE EDGE OF THE SCOPE DURING REMOVAL. ALL PIECES WERE REMOVED AND NO HARM TO THE PATIENT." FURTHER PATIENT, DEVICE AND EVENT DETAILS HAVE BEEN REQUESTED FROM THE USER FACILITY, BUT HAVE NOT YET BEEN RECEIVED AT THE TIME OF THIS SUBMISSION.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6865019 ↗