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Roadrunner G18792Recalls & reported problems

Cook Incorporated · Roadrunner, PC Double Flexible Tip Wire Guide With Hydrophilic Coating · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002187924), received between Jul 13, 2018 and Jul 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

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.

Most reported problems

Device problems

  • Peeled/Delaminated1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 13, 2018Peeled/Delaminated; Peeled/Delaminated

    IT WAS REPORTED, DURING A URETEROSCOPY STENTING PROCEDURE, WHEN INSERTING THE STENT WITH THE EXPIRATION DATE OF 02DEC2017, THE STENT DID NOT ADVANCE ON THE ROADRUNNER DOUBLE FLEXIBLE HYDROPHILIC WIRE GUIDE. IT WAS NOTICED THE SURFACE OF THE WIRE WAS NOTCHED WHICH PREVENTED THE STENT FROM ADVANCING ON THE WIRE. AS REPORTED, THE NOTCH WAS DESCRIBED AS THE "SURFACE PEELING OFF". ANOTHER WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7686451 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.