Roadrunner G18154Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002181540), received between Mar 16, 2018 and Aug 18, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50297681 ↗
• MalfunctionOct 21, 2025Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 27NOV2025. THE COATING OF THE WIRE GUIDE WAS ACTIVATED BY HYDRATION IN STERILE SALINE SOLUTION PRIOR TO REMOVAL FROM THE HOLDER FOLLOWING THE USUAL PROTOCOL. DURING THE INITIAL ADVANCEMENT OF THE WIRE GUIDE THROUGH THE CANAL, SLIGHT RESISTANCE WAS OBSERVED. WHEN THE WIRE GUIDE WAS PARTIALLY WITHDRAWN TO CHECK ITS CONDITION, THE TIP WAS NOTED TO BE FRAYED. THEREFORE, THE USE OF THE DEVICE WAS SUSPENDED AND REPLACED WITH A NEW WIRE GUIDE. THE DAMAGE TO THE TIP WAS DETECTED BEFORE THE GUIDE CAME INTO DIRECT CONTACT WITH THE PATIENT. THERE WAS NO SEPARATION OF ANY COMPONENTS INSIDE THE PATIENT. ONLY THE ENDOSCOPE CORRESPONDING TO THE PROCEDURE WAS BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346195 ↗
• MalfunctionMay 6, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED, PRIOR TO PATIENT CONTACT, WHEN WETTING THE ROADRUNNER, THE FIRM HYDROPHILIC WIRE GUIDE TO REMOVE IT FROM ITS SLEEVE AND MOUNT IT ON THE RIGID URETEROSCOPE, THE TIP WAS COMPLETELY FRAYED. THE PROCEDURE WAS COMPLETED USING A NEW SAME TYPE DEVICE. A PHOTO OF WHAT APPEARS TO SHOW UNRAVELED WIRE GUIDE WAS PROVIDED. NO ADVERSE EFFECTS OCCURRED SINCE THE EVENT WAS EVIDENT PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970311 ↗
• MalfunctionJul 18, 2024Material 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 19779367 ↗
• MalfunctionJun 24, 2024Peeled/Delaminated; Peeled/Delaminated

  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 19593411 ↗
• MalfunctionMay 9, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  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 19283184 ↗
• MalfunctionApr 15, 2024Peeled/Delaminated; Difficult to Remove; Inadequate Lubrication; Peeled/Delaminated; Difficult to Remove; Inadequate Lubrication

  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 19113358 ↗
• MalfunctionApr 5, 2024Material 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 19054668 ↗
• MalfunctionDec 4, 2023Material 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 18261101 ↗
• MalfunctionAug 24, 2022Break; Break

  AS REPORTED, WHILE OPENING THE PACKAGE OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE DURING A URETEROSCOPY, THE CORE OF THE WIRE WAS DISCOVERED EXPOSED. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286615 ↗
• MalfunctionApr 25, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A URETEROSCOPY, RETROGRADE PYELOGRAM, AND STENT PLACEMENT, WHEN REMOVING THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE FROM ITS HOLDER, IT WAS DISCOVERED THAT PART OF THE METAL WIRE WAS EXPOSED. THE DEVICE DID NOT MAKE PATIENT CONTACT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192554 ↗
• MalfunctionApr 14, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A URETEROSCOPY, RETROGRADE PYELOGRAM (RPG) AND STENTING PROCEDURE, IT WAS IT WAS DIFFICULT TO REMOVE A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE FROM ITS HOLDER. RESISTANCE WAS FELT ADVANCING THE WIRE GUIDE THROUGH AN OPEN-END CATHETER AND NARROWING OF THE CATHETER WAS NOTED AT THE PROXIMAL INJECTION PORT. THE WHITE JACKET OF THE ROADRUNNER WIRE GUIDE CUT AND STRIPPED OFF WHILE TRYING TO REMOVE THE IT FROM THE CATHETER. A NEW WIRE GUIDE FROM THE SAME LOT WAS USED AND EXPERIENCED THE SAME ISSUE. THE CASE WAS CONTINUED WITH A REPROCESSED GUIDEWIRE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115365 ↗
• MalfunctionJan 28, 2022Material Separation; Material Separation

  AS REPORTED, A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS STUCK WITHIN THE ORIGINAL CASING EVEN WHEN FLUSHED WITH WATER. THE SCRUB NURSE APPLIED A SMALL AMOUNT OF FORCE TO REMOVE THE GUIDE WIRE FROM ITS CASING, AND THE WIRE SNAPPED AT THE TIP. THEY NOTED THE BODY OF THE GUIDE WIRE APPEARED "DIFFERENT AND STIFF". A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EVENTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388752 ↗
• MalfunctionOct 20, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021: AS REPORTED, THERE WERE A QUANTITY OF TWO, ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE THAT WERE FOUND TO HAVE A SLIGHT SCRATCH IN THE MIDDLE OF THE DEVICE ON THE COATING AFTER IT WAS REMOVED FROM THE PACKAGE. BOTH DEVICES WERE FROM THE SAME REPORTED LOT AND THE ISSUE WAS DISCOVERED DURING THE SAME UNSPECIFIED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668637 ↗
• MalfunctionApr 30, 2021Peeled/Delaminated; Peeled/Delaminated

  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 11752135 ↗
• MalfunctionSep 1, 2020Device 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 Consequences Or Impact To Patient

  MAUDE report 10475798 ↗
• MalfunctionNov 21, 2019Flaked; Flaked

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354679 ↗
• MalfunctionMar 16, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS INSPECTED AT THE TIME OF RECEIPT AND A HAIR WAS OBSERVED INSIDE OF THE DEVICE PACKAGE. THIS DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7346180 ↗