Roadrunner G09029Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002090293), received between Sep 21, 2018 and Mar 3, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Flaked; Difficult to Advance; Inadequate Lubrication; Flaked; Difficult to Advance; Inadequate Lubrication

  AS REPORTED, DURING AN ANGIOGRAM, A ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE WAS STICKY AND GOT STUCK IN AN UNSPECIFIED CATHETER. LATEX GLOVES WERE WORN AND THE COATING WAS ACTIVATED WITH SALINE. THE WIRE FELT "RUFFLED" AND WHITE MATERIAL WAS FLAKING OFF THE WIRE, HOWEVER, THE USER IS UNSURE IF THE INNER WIRE WAS EXPOSED. THE FLAKING WAS NOTED WHEN FLUSHING THE WIRE AND ACTIVATION WENT "QUICKLY". THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 16479567 ↗
• InjuryNov 7, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING A VENOPLASTY PROCEDURE WHERE ACCESS WAS GAINED VIA RADIAL AND ILIAC ARTERIES USING FLOSSING TECHNIQUE, THE ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE HAD DIFFICULTY BEING REMOVED AND THE "WHITE COVER PEELED OFF" EXPOSING THE BLACK PORTION OF THE WIRE GUIDE. ACCORDING TO THE INITIAL REPORTER, THE ROADRUNNER WIRE GUIDE WAS INITIALLY INTRODUCED VIA RADIAL ACCESS, WHILE AN ADVANCE 35LP LOW-PROFILE PTA BALLOON DILATATION CATHETER WAS USED TO DILATE THE SUBCLAVIAN. AN ACCESS POINT WAS THEN GAINED IN THE PATIENT'S GROIN, WHERE THE BALLOON DEVICE WAS USED AGAIN TO DILATE THE GROIN SITE. AS THE BALLOON DEVICE WAS BEING REMOVED FROM THE GROIN, THE PHYSICIAN FELT SOME RESISTANCE FROM THE RADIAL END. AS MORE FORCE WAS APPLIED, THE PHYSICIAN THEN CONCLUDED THAT THE BALLOON DEVICE WAS "STUCK" ON THE ROADRUNNER WIRE GUIDE. THE VALVE OF THE ADVANCE 35LP LOW-PROFILE PTA BALLOON DILATATION CATHETER, DESCRIBED AS THE PORTION OF THE DEVICE WHERE THE WIRE GUIDE IS INSERTED, WAS SAID TO HAVE "SNAPPED" OFF THE BALLOON CATHETER (REFERENCE 1820334-2018-03256), AND ALL DEVICES WERE REMOVED FROM THE PATIENT TOGETHER. ADDITIONALLY, IT WAS REPORTED THAT PRIOR TO PULLING ALL DEVICES

  Patient problems: No Code Available

  MAUDE report 8046656 ↗
• MalfunctionSep 21, 2018Material Separation; Device Damaged by Another Device

  THE COMPLAINANT REPORTED THAT THE ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE WAS BINDING TO THE CATHETER DURING USE WHICH RESULTED IN A LOSS OF THE HYDROPHILIC COATING. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7899511 ↗