Roadrunner UniGlide G30492Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002304925), received between Jun 23, 2017 and Jun 5, 2024 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Flaked; Flaked

  UPON RETURN AND EVALUATION OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES, FLAKING WAS NOTED ON THE WIRES. THE WIRE WAS LUBRICIOUS; HOWEVER, SMALL WHITE ¿FLAKES¿ WERE NOTED NEAR THE MIDDLE OF THE WIRE, WHICH FELT STICKY WHEN DRIED. THERE WAS NO PATIENT INVOLVEMENT, AS THIS WAS FOUND DURING EVALUATION OF THE WIRE AT THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467285 ↗
• MalfunctionJun 5, 2024Flaked; Flaked

  UPON RETURN AND EVALUATION OF THREE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES, FLAKING WAS NOTED ON THE WIRES. THE WIRES WERE LUBRICIOUS; HOWEVER, SMALL WHITE ¿FLAKES¿ WERE NOTED NEAR THE MIDDLE OF THE WIRES, WHICH FELT STICKY WHEN DRIED. THERE WAS NO PATIENT INVOLVEMENT, AS THIS WAS FOUND DURING EVALUATION OF THE WIRES AT THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467273 ↗
• MalfunctionApr 4, 2024Flaked; Flaked

  AS ORIGINALLY REPORTED, DURING AN UNKNOWN PROCEDURE(S), FOUR ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES WERE "STICKY AND TACKY", EVEN WHEN KEPT WET IN A BASIN OF STERILE WATER WHEN NOT IN USE. THE WIRES WERE ATTEMPTED TO BE ADVANCED THROUGH A COOK CATHETER; HOWEVER, RESISTANCE WAS FELT AND THE WIRES BECAME "IMPOSSIBLE TO PASS". UPON REMOVAL OF THE WIRES, THE USER WAS CONCERNED THAT THE COATING WOULD "SHEAR OFF"; HOWEVER, THERE WAS NO REPORT ANY SHEARING SEPARATION OF THE COATING. PER THE REPORTER, THE "STICKY AND TACKY" FEELING WAS FELT WITH ANY DEVICE TRACKED OVER THESE WIRES. THE WIRES WERE REMOVED, AND A COMPETITOR'S WIRE WAS USED FOR THE PROCEDURE(S). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE ANY PATIENT'S BODY. THE PATIENT(S) DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THESE OCCURRENCES. ADDITIONAL INFORMATION WAS RECEIVED 11MAR2024, STATING THAT "CLEAR GELATINOUS AND SOMETIMES POWDERY" MATERIAL FLAKED FROM THE WIRES; HOWEVER, THE METAL WAS NOT EXPOSED. BOTH LATEX AND POWDERED GLOVES WERE WORN, AND THE COATING WAS INITIALLY ACTIVATED WITH HEPARINIZED SALINE. THE WIRES WERE USED IMMEDIATELY AFTER ACTIVATION AND WERE USED ONE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042119 ↗
• MalfunctionApr 4, 2024Flaked; Flaked

  AS ORIGINALLY REPORTED, DURING AN UNKNOWN PROCEDURE, A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS "STICKY AND TACKY", EVEN WHEN KEPT WET IN A BASIN OF STERILE WATER WHEN NOT IN USE. THE WIRE WAS ATTEMPTED TO BE ADVANCED THROUGH A COOK CATHETER, HOWEVER, RESISTANCE WAS FELT AND THE WIRE BECAME "IMPOSSIBLE TO PASS". UPON REMOVAL OF THE WIRE, THE USER WAS CONCERNED THAT THE COATING WOULD "SHEAR OFF"; HOWEVER, THERE WAS NO REPORT ANY SHEARING/SEPARATION OF THE COATING. PER THE REPORTER, THE "STICKY AND TACKY" FEELING WAS FELT WITH ANY DEVICE TRACKED OVER THIS WIRE. THE WIRE WAS REMOVED, AND A COMPETITOR'S WIRE WAS USED FOR THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED 11MAR2024, STATING THAT "CLEAR GELATINOUS AND SOMETIMES POWDERY" MATERIAL FLAKED FROM THE WIRE; HOWEVER, THE METAL WAS NOT EXPOSED. BOTH LATEX AND POWDERED GLOVES WERE WORN, AND THE COATING WAS INITIALLY ACTIVATED WITH HEPARINIZED SALINE. THE WIRE WAS USED IMMEDIATELY AFTER ACTIVATION AND WAS USED ONE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041921 ↗
• MalfunctionMar 5, 2024Flaked; Material Separation; Flaked; Material Separation

  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 18841233 ↗
• MalfunctionJan 22, 2024Material Separation; Material Separation

  AS REPORTED, DURING AN ANGIOGRAM, THE COATING FLAKED OFF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE COATING WAS ACTIVATED BY WIPING THE DEVICE DOWN ONCE WITH NORMAL SALINE AND 2X2 GAUZE. ALTHOUGH THE WIRE WAS REPORTEDLY KEPT HYDRATED WHILE NOT IN USE, THE WIRE WAS ONLY USED ONE TIME. THE PHYSICIAN REMOVED THE COMPLAINT DEVICE TO EXCHANGE IT WITH A STIFFER WIRE. UPON PLACEMENT OF THE COMPLAINT WIRE ON THE BACK TABLE, THE USER NOTED THAT THE HYDROPHILIC COATING WAS FLAKING OFF THE WIRE. IT IS UNKNOWN IF ANY OF THE COATING HAD COME OFF INSIDE THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551951 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  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 18143038 ↗
• MalfunctionAug 1, 2023Material Separation; Material Separation

  AS REPORTED, DURING AN ENDOVASCULAR LOWER EXTREMITY ARTERIOGRAM WITH POSSIBLE INTERVENTION, THE COATING CAME OFF OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. THE WIRE, WHICH WAS USED ONE TIME, WAS NOT ALTERED PRIOR TO USE. LATEX GLOVES WERE WORN. THE HYDROPHILIC COATING WAS ACTIVATED WITH NORMAL SALINE AND THE WIRE WAS KEPT HYDRATED WHEN NOT IN USE. COMMON FEMORAL ACCESS WAS OBTAINED TO TARGET THE SUPERFICIAL FEMORAL ARTERY. AFTER INSERTING THE WIRE, THE COATING BECAME STICKY AND CAME OFF OF THE WIRE. CATHETERS STUCK ON THE WIRE. ANOTHER MANUFACTURER'S WIRE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437615 ↗
• MalfunctionDec 16, 2022Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated

  AS REPORTED, DURING A RIGHT LEG ANGIOGRAM, THE HYDROPHILIC COATING OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE SEPARATED FROM THE DEVICE. ACCESS WAS GAINED IN THE LEFT GROIN FOR TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY THROUGH A 90% OCCLUSION. THE DEVICE WAS HANDLED WITH LATEX GLOVES AND ACTIVATED BY WETTING WITH SALINE. THE DEVICE WAS INSERTED AND REMOVED THREE TIMES BEFORE THE HYDROPHILIC COATING SEPARATION WAS NOTED; THE DEVICE WAS KEPT IN A BOWL OF SALINE BETWEEN USES. DURING THE THIRD REMOVAL, THE WIRE FELT "GRAINY", AND PART OF THE COATING WAS FLAKING OFF OF THE DEVICE. THIS WIRE WAS NOT USED ANY FURTHER IN THE PROCEDURE, AND ANOTHER OF THE SAME WIRE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996952 ↗
• MalfunctionOct 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, WHILE RESTOCKING INVENTORY, FOREIGN MATTER WAS NOTED INSIDE A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S PACKAGE. THIS WAS NOT NOTED DURING A PROCEDURE; THEREFORE, NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555158 ↗
• MalfunctionApr 26, 2021Peeled/Delaminated; Peeled/Delaminated

  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 11724057 ↗
• MalfunctionSep 14, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 30SEP2020. RIGHT FEMORAL ACCESS WAS OBTAINED FOR THE DIAGNOSTIC PROCEDURE. THE ANATOMY WAS REPORTEDLY CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE AND THE DEVICE DID NOT KINK. LATEX SURGICAL GLOVES WERE WORN DURING THE PROCEDURE. THE HYDROPHILIC COATING WAS ACTIVATED WITH AN UNKNOWN SOLUTION TO ¿PURGE¿ THE DEVICE FOR AT LEAST TEN MINUTES AND THE DEVICE WAS KEPT IN A TRAY WITH THE SOLUTION PRIOR TO USE. THE DEVICE WAS USED ONLY ONE TIME. THE WIRE REPORTEDLY ¿LOST¿ THE HYDROPHILIC COATING AND FLAKING WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10528018 ↗
• MalfunctionApr 2, 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 Consequences Or Impact To Patient

  MAUDE report 9916971 ↗
• MalfunctionApr 2, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 02JUN2020 STATING THAT NO ATTEMPTS WERE MADE TO ACTIVATE THE HYDROPHILIC COATING. NO MOISTURE CAME INTO CONTACT WITH THE WIRE GUIDE. THE HYDROPHILIC COATING WAS NOT FLAKING OR COMING OFF OF THE WIRE GUIDE. THE DEVICE PACKAGING WAS IN "GOOD CONDITION" AND STORED IN ALIGNMENT WITH THE FACILITY PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916308 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis

  MAUDE report 8598079 ↗
• 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 7881174 ↗
• MalfunctionFeb 20, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TRAINING COURSE FOR A DIFFICULT INFERIOR VENA CAVA (IVC) FILTER REMOVAL USING A PIG, THE LOOP WIRE TECHNIQUE WAS USED TO REVERSE THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE THROUGH THE BODY OF THE IVC FILTER. THE WIRE GUIDE WAS EXTERNALIZED AND WHILE CONTROLLING BOTH ENDS OF THE WIRE, TENSION WAS APPLIED AS THE SHEATH WAS DRIVEN DOWN OVER THE WIRE TO RETRIEVE THE FILTER. THE WIRE GUIDE THEN SNAPPED IN HALF. AS BOTH ENDS OF THE WIRE WERE EXTERNALIZED, THERE WAS NO NEED FOR RETRIEVAL OF THE WIRE. THE ACCESS SITE UTILIZED WAS THE RIGHT INTERNAL JUGULAR; THE PIG'S ANATOMY WAS NOT CALCIFIED OR TORTUOUS. 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 7282702 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO A LOWER LEG ANGIOGRAM PROCEDURE USING A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE, IT WAS NOTED THAT THE HYDROPHILIC COATING ON THE WIRE WAS PEELING OFF. LATEX GLOVES WERE WORN FOR THIS PROCEDURE. THE COATING WAS ACTIVATED FOR LESS THAN 5 MINUTES WITH A WET GAUZE. THE INTENDED ACCESS SITE WAS THE RIGHT GROIN. THE PROCEDURE DID NOT ADVANCE FAR ENOUGH TO TELL IF THE PATIENT'S ANATOMY WAS TORTUOUS OR CALCIFIED. ADDITIONAL INFORMATION ABOUT PATIENT OUTCOME OR ADVERSE EFFECTS HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665325 ↗