Roadrunner G09607Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002096073), received between Sep 20, 2018 and Sep 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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-1838-2022 · 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 30, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954661 ↗
• MalfunctionOct 2, 2023Unraveled Material; Unraveled Material

  AS REPORTED, PRIOR TO PATIENT CONTACT, A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE UNRAVELED. THE HYDROPHILIC COATING WAS ACTIVATED USING NORMAL SALINE AND THE WIRE WAS IMMEDIATELY WITHDRAWN FROM ITS HOLDER. HOWEVER, THE TIP OF THE WIRE PARTIALLY DETACHED AFTER REMOVAL FROM THE HOLDER. THE TIP REMAINED ATTACHED BY THE "INTERNAL FIBERS". THE DEVICE WAS NOT USED, AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17856770 ↗
• MalfunctionJan 27, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED, TWENTY-FIVE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367763 ↗
• MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER PARTICLE WAS IDENTIFIED INSIDE THE PACKAGING OF THE ROAD RUNNER NIMBLE HYDROPHILIC WIRE GUIDE. THE PARTICLE WAS NOTED PRIOR TO OPENING AND WAS NOT USED ON A PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854949 ↗
• MalfunctionSep 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, DURING INSPECTION OF THE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE ON (B)(6), A FOREIGN PARTICLE WAS NOTED INSIDE THE SEALED PACKAGE. THE DEVICE WAS NOT USED DURING A PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7914261 ↗
• MalfunctionSep 20, 2018Mechanical Problem; Material Separation; Stretched

  IT WAS REPORTED THAT THE ROADRUNNER WIRE CAUGHT ON THE TIP OF THE CATHETER WHILE IT WAS BEING REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THE DISTAL TIP WAS SEPARATED AND THE COIL WAS ELONGATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894702 ↗