Roadrunner G17542Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002175426), received between Jun 27, 2019 and Dec 15, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed 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 23804397 ↗
• MalfunctionJan 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S STERILIZED PACKAGE CONTAINED A HAIR. THE HAIR WAS FOUND DURING VERIFICATION PROCESS CONDUCTED BY LOGISTIC DEPARTMENT, AND IT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149157 ↗
• MalfunctionJul 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S PRIMARY PACKAGE CONTAINED FOREIGN MATTER, "A SMALL PURPLE PLASTIC PART". THE SMALL PURPLE PLASTIC PART WAS FOUND WHEN THE DISTRIBUTOR RECEIVED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721480 ↗
• InjuryAug 9, 2021Material Separation; Material Separation

  AS REPORTED, DURING A RIGHT SUPINE PERCUTANEOUS LITHOTRIPSY WITH PYELOSCOPY AND LASER OF THE KIDNEY, THE TIP OF A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE SEPARATED. THE WIRE GUIDE WAS INSERTED INTO A COOK SHEATH BUT COULD NOT PASS BEYOND THE PARTIAL STAGHORN STONE. THE STONE WAS ACCESSED WITH A FLEXIBLE URETEROSCOPE VIA RETROGRADE APPROACH. AS THE STONE WAS LASERED TO ALLOW FOR PASSAGE OF THE ANTEGRADE WIRE, THE TIP OF THE WIRE WAS LASERED AND SEPARATED. THE USER CONTINUED TO USE THE LASER, AND THE WIRE WAS THEN ABLE TO ADVANCE. DILATION OF THE TRACT WAS COMPLETED, AND THE TIP OF THE WIRE WAS FOUND WITHIN THE SCOPE AS THE STONE FRAGMENTS WERE REMOVED. THE WIRE FRAGMENT WAS REMOVED WITH THREE-PRONG GRASPERS, AND THE PROCEDURE WAS CONTINUED WITHOUT FURTHER ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12294222 ↗
• MalfunctionFeb 28, 2020Material Separation; Material Separation

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9768603 ↗
• InjuryJun 27, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Internal Organ Perforation

  MAUDE report 8740004 ↗
• InjuryJun 27, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Internal Organ Perforation

  MAUDE report 8739959 ↗
• InjuryJun 27, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Internal Organ Perforation

  MAUDE report 8739882 ↗
• InjuryJun 27, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Internal Organ Perforation

  MAUDE report 8739732 ↗