Roadrunner UniGlide G56177Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002561779), received between Apr 10, 2015 and Jun 10, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Flaked” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE INVOLVING THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S COATING SHEARED OFF THE WIRE. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY TO TARGET THE LEFT LEG. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE PROXIMAL SFA WAS CALCIFIED AND SIGNIFICANTLY STENOSED/OCCLUDED. THE BIFURCATION ANGLE WAS NORMAL. A COOK SHEATH AND THE ROADRUNNER WIRE, WHICH WAS NOT ALTERED PRIOR TO USE, WERE ADVANCED DOWN TO A CTO (CHRONIC TOTAL OCCLUSION) ¿CAP¿. THE PHYSICIAN ATTEMPTED TO PROTRUDE THROUGH THE CAP; HOWEVER, THE SHEATH AND WIRE WERE GETTING CAUGHT AND WOULD NOT ADVANCE. ANOTHER MANUFACTURER¿S CROSSING CATHETER WAS ALSO IN PLACE. THE WIRE, CATHETER, AND SHEATH WERE REMOVED AT THE SAME TIME. AS THE DEVICES WERE PULLED OUT, THE ROADRUNNER WIRE¿S COATING SHEARED OFF THE WIRE. IT IS UNKNOWN IF ANY OF THE WIRE¿S COATING REMAINED IN THE PATIENT. THE USER ALSO NOTED THAT A RADIOPAQUE BAND, BELIEVED TO BE FROM THE OTHER MANUFACTURER¿S CROSSING CATHETER, REMAINED IN THE PATIENT. THE PHYSICIAN CHECKED THE COOK SHEATH UNDER FLUOROSCOPY AFTER THE SHEATH WAS REMOVED FROM THE PATIENT, CONFIRMING THAT THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179098 ↗
• MalfunctionJun 28, 2024Flaked; Flaked

  AS REPORTED ORIGINALLY REPORTED, FIVE ROAD RUNNER 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 19632546 ↗
• MalfunctionApr 11, 2023Flaked; Flaked

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, THE COATING FLAKED FROM A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. THE WIRE WAS FLUSHED PRIOR TO USE TO ACTIVATE THE HYDROPHILIC COATING AND WAS REPORTEDLY MADE "EXTRA SLOPPY WET". THE HYDROPHILIC COATING WAS NOT ACTIVATED LONG, PER THE REPORTER, BUT THE WIRE WAS KEPT HYDRATED WHEN NOT IN USE. THE WIRE WAS NOT ALTERED PRIOR TO USE. IMMEDIATELY UPON THE FIRST USE OF THE WIRE WITHIN ANOTHER MANUFACTURER'S 5FRENCH SHEATH AND DILATOR, THE WIRE WAS NOTED TO BE STICKY AND FELT GRITTY. THE WIRE WAS DIFFICULT TO REMOVE FROM THE SHEATH; HOWEVER, IT WAS ABLE TO BE REMOVED, AND ANOTHER WIRE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS FINE. THE USER NOTED THAT THE COATING OF THE WIRE REPORTEDLY FLAKED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16713356 ↗
• MalfunctionAug 10, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303004 ↗
• MalfunctionFeb 26, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11387124 ↗
• MalfunctionAug 24, 2020Unraveled Material; Unraveled Material

  IT WAS REPORTED, DURING A PD CATHETER EVALUATION PROCEDURE, THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE UNRAVELED. ACCORDING TO THE INITIAL REPORTER, THE WIRE'S COATING UNRAVELED WHEN HE WAS REMOVING THE DEVICE. 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 10443055 ↗
• MalfunctionApr 9, 2020Flaked; Flaked

  AS REPORTED, DURING AN UNKNOWN NUMBER OF PROCEDURES INVOLVING FEMORAL ACCESS, THE COATING BECAME STICKY AND HAS COME OFF OF AN UNKNOWN NUMBER OF ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES. OTHER MANUFACTURER'S DEVICES, SUCH AS BALLOONS, WERE REPORTEDLY USED DURING THE PROCEDURES. THE WIRES WERE NOT ALTERED PRIOR TO USE AND KINKING WAS NOT NOTED. POWDERED GLOVES WERE WORN AND THE DEVICES WERE HYDRATED WITH HEPARINIZED SALINE. PER THE USER, THE WIRES WOULD NOT ACTIVATE APPROPRIATELY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE ANY PATIENT¿S BODY. THE PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943164 ↗
• MalfunctionMar 17, 2020Flaked; Flaked

  ADDITIONAL INFORMATION RECEIVED 18MAR2020. AS REPORTED, THE COATING CAME OFF OF MULTIPLE DEVICES DURING AN UNKNOWN NUMBER OF FISTULA REVISION PROCEDURES. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE WIRE WAS HYDRATED WITH HEPARINIZED SALINE AND HANDLED WITH POWDERED GLOVES DURING USE. NO KINKING WAS OBSERVED. 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 9843354 ↗
• MalfunctionNov 4, 2019Separation Problem; Separation Problem

  ADDITIONAL INFORMATION WAS RECEIVED 07NOV2019. AS REPORTED, THE COATING OF THE DEVICE WAS ACTIVATED PRIOR TO USE. UPON INSERTION INTO A BALLOON CATHETER, RESISTANCE WAS OBSERVED IN ATTEMPTING TO ADVANCE THE WIRE, AND DETACHED COATING WAS THEN NOTED. NO DETACHED COATING WAS FOUND IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272401 ↗
• MalfunctionOct 11, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE TIP OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE BROKE DURING A PERITONEAL DIALYSIS CATHETER PLACEMENT. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ALTHOUGH REQUESTED, ADDITIONAL EVENT DETAILS, PATIENT DEMOGRAPHICS AND OUTCOME HAS NOT BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7956890 ↗
• MalfunctionSep 26, 2018Material Fragmentation

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

  Patient problems: No Patient Involvement

  MAUDE report 7911530 ↗
• MalfunctionSep 26, 2018Material Fragmentation

  IT WAS REPORTED THAT THE COATING OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS FLAKING. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7911115 ↗
• MalfunctionSep 26, 2018Material Protrusion/Extrusion

  THE COMPLAINANT REPORTED THAT A SHARP POINT OF THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE PROTRUDED FROM THE CATHETER. THIS WAS NOTED AFTER THE DEVICES WERE REMOVED FROM THE PATIENT TO COMPLETE THE VENOGRAM. 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 7910144 ↗
• MalfunctionJun 16, 2017Flaked; Flaked

  IT WAS REPORTED THAT THE HYDROPHILIC COATING ON THE ROADRUNNER UNIGLIDE DEVICE APPEARED TO BE COMING OFF OF THE DEVICE DURING THE SFA INTERVENTION PROCEDURE. THE REPORTER STATED THAT THIS OCCURRED ON THE DISTAL END OF THE GUIDE, AWAY FROM THE PATIENT, AND NONE OF COATING CAME OFF INSIDE THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648158 ↗
• MalfunctionMay 11, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PERIPHERAL ANGIOGRAM, THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS NOT ABLE TO BE ADVANCED. WHEN IT WAS PULLED OUT, THE MANDRIL WAS EXPOSED AND THE HYDROPHILLIC COATING WAS PEELED OVER IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER UNIGLIDE. 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 6561775 ↗
• MalfunctionApr 10, 2015Other (for use when an appropriate device code cannot be identified)

  DURING A CEREBRAL ANGIOGRAM, THE TECH NOTICED THAT THE HYDROPHILIC COATING HAD BECOME SEPARATED MID SHAFT OF THE WIRE. THE WIRE WAS SUBSEQUENTLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4691749 ↗