Roadrunner UniGlide G56174Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002561748), received between Feb 23, 2017 and Sep 18, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Flaked” (6 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Flaked; Flaked

  AS ORIGINALLY REPORTED BY THE CUSTOMER, A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE BECAME "GRITTY" AND ROUGH ONCE THE HYDROPHILIC COATING WAS ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT. DURING EVALUATION OF UNUSED AND SEALED WIRES THAT WERE RETURNED FROM THE CUSTOMER, THE COATING FLAKED FROM ONE OF THE WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249174 ↗
• MalfunctionJun 28, 2024Flaked; Flaked

  AS REPORTED ORIGINALLY REPORTED, FIVE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES WERE "TACKY". A SECTION OF THE DEVICES DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THESE OCCURRENCES. ADDITIONAL INFORMATION WAS RECEIVED 03JUN2024. "BLACK FLAKES" WERE NOTED TO COME OFF THE WIRE GUIDE COATING; HOWEVER, NO METAL/MANDREL WAS EXPOSED. STANDARD, NON-POWDERED LATEX GLOVES WERE WORN. THE COATING WAS ACTIVATED/HYDRATED IN A BOWL UNDER A WET BLUE TOWEL AND ACTIVATED IMMEDIATELY BEFORE INSERTION/REMOVAL THROUGH AN UNSPECIFIED CATHETER. ADDITIONALLY, DURING EACH CATHETER EXCHANGE, THE WIRES WERE WIPED DOWN WITH A "VERY WET" 4X4 TOWEL DURING EACH INSERTION. THE DEVICES WERE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632648 ↗
• MalfunctionApr 29, 2024Flaked; Flaked

  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 19207189 ↗
• MalfunctionSep 1, 2022Flaked; Material Separation; Flaked; Material Separation

  AS REPORTED, THE HYDROPHILIC COATING CAME OFF OF "SEVERAL" (UNSPECIFIED NUMBER) ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335444 ↗
• MalfunctionMar 5, 2020Flaked; Flaked

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE COATING OF TWO ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES WOULD NOT ACTIVATE APPROPRIATELY, BECAME STICKY, AND CAME OFF THE WIRE. THE HYDROPHILIC COATING WAS ACTIVATED WITH SALINE, AND THE DEVICE REMAINED IN SALINE WHEN NOT IN USE THROUGHOUT THE PROCEDURE. LATEX GLOVES WERE WORN. ACCESS WAS OBTAINED IN THE LEFT UPPER ARM. THE ANATOMY WAS NOT REPORTED TO BE CALCIFIED OR TORTUOUS. THE WIRE WAS NOT ALTERED PRIOR TO USE AND KINKING WAS NOT OBSERVED. FLAKING OF THE COATING WAS OBSERVED. THE FLAKES WERE CLEAR BUT REPORTEDLY APPEARED WHITE WHILE ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. PATIENT CARE WAS NOT IMPACTED, AND NO PORTION OF THE DEVICE OR COATING WAS LEFT IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 Consequences Or Impact To Patient

  MAUDE report 9793170 ↗
• MalfunctionFeb 24, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 9746158 ↗
• MalfunctionSep 28, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TORQUE DEVICE FELT LIKE IT WAS GRINDING ON THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE, AND IT WAS LATER NOTED THAT IT HAD CAUSED SEVERAL TEARS IN THE COATING. THE PROCEDURE WAS CONTINUED WITH A NEW DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919439 ↗
• MalfunctionSep 26, 2018Material Fragmentation

  IT WAS REPORTED THAT THE COATING OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS FLAKING PRIOR TO USE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7910983 ↗
• MalfunctionSep 25, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS ROUGH IN SEVERAL PLACES, AND IT WAS LATER FOUND TO HAVE A DRIED WHITE SUBSTANCE ON THE SHAFT. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907499 ↗
• MalfunctionSep 17, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING THE PTA PROCEDURE, WHEN THE HYDROPHILIC WIRE WAS PUSHED INTO THE CATHETER WHILE IN A VESSEL, A WHITE SUBSTANCE ACCUMULATED AT THE EDGE OF THE CATHETER. IT WAS FURTHER NOTED THAT A WHITE SUBSTANCE WAS PEELING OFF THE WIRE. THE CATHETER WAS WITHDRAWN IMMEDIATELY AND ANOTHER DEVICE WAS USED, AND THERE WERE NO ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881346 ↗
• MalfunctionSep 17, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING THE PTA PROCEDURE, WHEN THE HYDROPHILIC WIRE WAS PUSHED INTO THE CATHETER WHILE IN A VESSEL, A WHITE SUBSTANCE ACCUMULATED AT THE EDGE OF THE CATHETER. IT WAS FURTHER NOTED THAT A WHITE SUBSTANCE WAS PEELING OFF THE WIRE. THE CATHETER WAS WITHDRAWN IMMEDIATELY AND ANOTHER DEVICE WAS USED, AND THERE WERE NO ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881025 ↗
• InjuryMay 11, 2018Flaked; Flaked

  IT WAS REPORTED THAT AT THE END OF A FISTULOGRAM WITH ANGIOPLASTY PROCEDURE, THE PHYSICIAN NOTED SOME OF THE COATING OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE HAD SHEARED OFF AND REMNANTS REMAINED IN THE PATIENT'S ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE TIME OF THIS REPORT, THE COATING STILL REMAINS IN THE PATIENT. PER THE COMPLAINANT, A PROCEDURE HAS NOT BEEN SCHEDULED TO REMOVE THE REMNANTS. THERE HAVE NOT BEEN ANY REACTIONS TO THE FOREIGN BODY AND THE REMNANTS SEEN ON IMAGING WERE MINIMAL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAS NOT REQUIRED ANY ADDITIONAL PROCEDURES NOR ADVERSE EFFECTS RELATED TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7507186 ↗
• MalfunctionAug 31, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS USED IN A RADIAL CEPHALIC FISTULA ARTERIOGRAM. IT WAS REPORTED THAT THE WIRE WAS UNABLE TO ADVANCE WITH EASE DUE TO CALCIFICATION OF THE ARTERY. THE WIRE WAS REMOVED WITH SOME DIFFICULTY AND IT WAS OBSERVED TO BE PARTIALLY DETACHED FROM THE HYDROPHILIC COATING ON THE TIP. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 Known Impact Or Consequence To Patient

  MAUDE report 6834421 ↗
• MalfunctionFeb 23, 2017Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE WIRE THROUGH THE INTRODUCER, THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE DIDN'T NAVIGATE AS WELL. IT WAS STATED THAT ONCE THE PHYSICIAN REMOVED THE WIRE GUIDE, HE NOTED THAT THE ¿WIRE WAS NAKED¿, AS IN THE COATING OF THE WIRE PEELED OFF. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353111 ↗