Roadrunner UniGlide G30506Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002305069), received between Dec 9, 2014 and Mar 26, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (9 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Flaked; Chemical Problem; Flaked; Chemical Problem

  AS REPORTED, PRIOR TO USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE, THE "COATING" CAME OFF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. PER THE REPORTER, A MILKY FLUID FORMED FROM THE TIP OF ANOTHER MANUFACTURER¿S PIGTAIL CATHETER UPON INTRODUCTION OF THE WIRE INTO THE CATHETER DURING PREPARATION OF THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699670 ↗
• MalfunctionOct 17, 2024Material Deformation; Material Deformation

  AS ORIGINALLY REPORTED, SHORTLY AFTER INSERTION OF THE DEVICE DURING AN UNKNOWN PROCEDURE INVOLVING THE LOWER LEG, A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS DIFFICULT TO MANIPULATE WITH THE TORQUING DEVICE. ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE LEFT LOWER EXTREMITY. THE ANATOMY WAS CALCIFIED. LATEX GLOVES WERE WORN, AND THE WIRE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS SOAKED IN SALINE TO ACTIVATE THE COATING FOR THIRTY SECONDS PRIOR TO USE. THE WIRE WAS USED ONE TIME, AND IT WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. THE WIRE WAS REMOVED, AND THE USER NOTED A ¿BUMP¿ ON THE END OF THE WIRE; HOWEVER, FLAKING WAS NOT NOTED. ANOTHER DEVICE OF THE SAME TYPE 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 PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE COATING/JACKET WAS DAMAGED AND WRINKLED/TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20475845 ↗
• MalfunctionJul 31, 2023Flaked; 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 17428183 ↗
• MalfunctionMay 16, 2023Material Separation; Material Separation

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF AN OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY, THE COATING SEPARATED FROM A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. THE ANATOMY WAS TORTUOUS. THE WIRE GUIDE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A COOK ROSEN WIRE, WITHOUT FURTHER PROBLEMS. NO PART OF THE WIRE WAS LEFT BEHIND. 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 16939588 ↗
• MalfunctionFeb 9, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A RECANALIZATION PROCEDURE INVOLVING LITHOPLASTY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AND STENTING OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE COATING PEELED FROM A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE. THE ANATOMY WAS "MASSIVELY" CALCIFIED AND THE SFA WAS OCCLUDED. LATEX GLOVES WERE WORN, AND THE DEVICE'S COATING WAS ACTIVATED IN A BOWL OF NORMAL SALINE FOR THIRTY MINUTES PRIOR TO USE. THE WIRE, WHICH WAS ONLY USED ONE TIME, WAS NOT ALTERED PRIOR TO USE AND REPORTEDLY LOOKED "STANDARD" AT THE BEGINNING OF THE PROCEDURE. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY FOR A CONTRALATERAL APPROACH. THE WIRE WAS REPORTEDLY DIFFICULT TO ADVANCE FROM THE MOMENT OF INSERTION. IN ORDER TO INSERT A CROSSOVER SHEATH, ANOTHER MANUFACTURER'S 5-FRENCH CATHETER WAS ADVANCED OVER THE WIRE GUIDE; HOWEVER, ADVANCEMENT WAS DESCRIBED AS TEDIOUS AND THE CATHETER DID NOT ADVANCE EASILY OVER THE WIRE GUIDE. THE WIRE THEN BECAME STUCK IN THE CATHETER AND WAS UNABLE TO MOVE FORWARD OR BACKWARD. THE WIRE AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT. PER THE REPORTER, THE COATING HAD PEELED FROM THE WIRE. NO PART OF THE COATING MATERIAL WAS LEFT IN THE PATIENT. AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16341848 ↗
• MalfunctionFeb 7, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS LOSING MATERIAL WHEN THE BALLOON WAS PULLED FROM THE WIRE. THIS OCCURRED OUTSIDE OF THE PATIENT'S BODY BUT WAS DURING A TRANSFEMORAL ACCESS, CROSSOVER FROM LEFT TO RIGHT, PERCUTANEOUS ASPIRATION-THROMBECTOMY, STENTING, AND POST DILATION PROCEDURE. IT WAS AN UNCOMPLICATED PUNCTURE INTO THE TRANSFEMORAL ON THE LEFT SIDE, THE DEVICE WAS INSERTED, AND CROSSOVER WITH SUPPORT CONTRA CATHETER. THE 6FR SHEATH WAS PLACED IN THE HEIGHT OF THE RIGHT EXTERNAL ILIAC. OVERVIEW SHOWED A TOTAL OCCLUSION OF THE SUPERIOR FEMORAL ARTERY FROM THE FEMORAL FORK TO THE ABDUCTOR CANAL. COLLATERALES OF PROFUNDA ARE THERE, THREE-VESSEL SUPPLY ON THE LOWER LEG. A 6FR ASPIRATION CATHETER WAS INSERTED OVER THE WIRE IN SFA. MANY FRESH RED THROMBI CAN BE RECOVERED, BUT ALSO MASSIVE RESTENOSIS AND WALL HARDENING NON-ASPIRABLE THROMBUS PARTS WERE NOTED. THEY INSERTED THE WIRE OVER TWO OVERLAPPING ZPTX STENTS. POST DILATIONS WERE DONE WITH BSC BALLOON CATHETER. THE RESULTS WAS GOOD. AS THEY WERE PULLING THE BALLOON BACK OVER THE WIRE, THE MATERIAL STARTED TO SHEAR OFF THE WIRE. THE WIRE COATING HAD BEEN ACTIVATED Y USING A MIX OF H2O AND NACL. A SECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472025 ↗
• MalfunctionOct 28, 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 12711614 ↗
• MalfunctionSep 23, 2021Peeled/Delaminated; Peeled/Delaminated

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521237 ↗
• MalfunctionSep 9, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, THE SURFACE OF A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS DAMAGED DURING A PERIPHERAL STENT PLACEMENT. THE DEVICE WAS ACTIVATED IN SALINE AND INSERTED VIA CONTRALATERAL ACCESS WITHOUT COMPLICATION, AND ANOTHER MANUFACTURER'S CATHETERS AND SHEATH WERE ADVANCED TO A TOTAL OCCLUSION IN THE CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. PASSAGE THROUGH THE OCCLUSIVE SECTION AND SUBSEQUENT PRE-DILATATION WAS DIFFICULT. FOLLOWING ONE UNSUCCESSFUL ATTEMPT, ANOTHER MANUFACTURER'S REENTRY SYSTEM WAS PLACED. THE ROADRUNNER WIRE GUIDE WAS THEN REMOVED FROM THE PATIENT TO BE EXCHANGED FOR A THINNER WIRE. AS THE DEVICE WAS PREPARED TO BE USED AGAIN, DAMAGE WAS NOTED ON THE SURFACE OF THE DEVICE. PHOTOS OF THE DEVICE PROVIDED BY THE USER APPEARED TO SHOW THE POLYURETHANE COATING HAVING SEPARATED FROM THE DEVICE. A NEW WIRE WAS USED TO SUCCESSFULLY PLACE FOUR STENTS. 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 12447071 ↗
• MalfunctionAug 5, 2021Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284699 ↗
• MalfunctionApr 22, 2021Material 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 11711484 ↗
• MalfunctionMay 27, 2020Peeled/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 Information

  MAUDE report 10091863 ↗
• MalfunctionNov 4, 2019Separation Problem; Separation Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9271615 ↗
• MalfunctionMar 7, 2019Peeled/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 Consequences Or Impact To Patient

  MAUDE report 8399964 ↗
• MalfunctionSep 26, 2018Material Fragmentation; Material Too Rigid or Stiff; Physical Resistance/Sticking

  THE COMPLAINANT REPORTED THAT THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE BECAME VERY STICKY THE MOMENT IT MADE PATIENT CONTACT, SO IT WAS DIFFICULT TO PASS THE WIRE THROUGH THE CATHETER. THE RIGHT COMMON FEMORAL WAS ACCESSED TO TREAT THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY), AND THE PATIENT'S ANATOMY WAS NOTED TO BE CALCIFIED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE FOR THE SFA STENT. IT WAS FURTHER NOTED THAT THE COATING ON THE WIRE WAS ¿FLAKY¿ AND HAD A ROUGH TEXTURE IN SEVERAL PLACES. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7912058 ↗
• 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 7911387 ↗
• MalfunctionSep 20, 2018Break

  IT WAS REPORTED THAT THE TORQUE DEVICE CAUSED DAMAGE TO MULTIPLE LOCATIONS ON THE WIRE¿S HYDROPHILIC COATING. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THE COATING WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894471 ↗
• MalfunctionSep 20, 2018Break

  IT WAS REPORTED THAT THE ROADRUNNER WIRE RECEIVED DAMAGE TO ITS HYDROPHILIC COATING DUE TO THE TORQUE DEVICE. NO MATERIAL WAS LOST IN THE PATIENT. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894401 ↗
• MalfunctionSep 19, 2018Material Fragmentation; Device Damaged by Another Device

  IT WAS REPORTED THAT THE ROADRUNNER WIRE RECEIVED DAMAGE TO ITS HYDROPHILIC COATING DUE TO THE TORQUE DEVICE AND SOME OF THE COATING WAS TAKEN OFF. NO MATERIAL WAS LOST IN THE PATIENT. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891702 ↗
• MalfunctionSep 19, 2018Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ROADRUNNER WIRE¿S HYDROPHILIC COATING WAS DAMAGED IN MULTIPLE PLACES, EXPOSING THE CORE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER DISCOVERED THAT THERE WERE MULTIPLE CUTS AND TEARS IN THE COATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891609 ↗
• MalfunctionSep 18, 2018Structural Problem; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WAS STICKY AND DIFFICULT TO ADVANCE. IT WAS LATER FOUND THAT THE WIRE'S HYDROPHILIC COATING HAD MOSTLY COME OFF. THE PROCEDURE WAS STILL COMPLETED WITH THIS DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886992 ↗
• MalfunctionSep 18, 2018Material Separation; Structural Problem; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE WOULD NOT ADVANCE THROUGH THE CATHETER DURING A PERIPHERAL ARTERIAL DISEASE PROCEDURE, AND THEN IT WAS DIFFICULT TO REMOVE FROM THE CATHETER. THE WIRE WAS FOUND TO BE STICKY AND TACKY, AND THE BALLOON COULD NOT BE ADVANCED OVER IT. IT WAS LATER DISCOVERED THAT THE HYDROPHILIC COATING HAD SEPARATED FROM THE DEVICE. THE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES, AND NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886933 ↗
• MalfunctionSep 18, 2018Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE COATING BEGAN TO SEPARATE FROM THE WIRE, PREVENTING A BALLOON FROM ADVANCING OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886855 ↗
• MalfunctionSep 18, 2018Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION FOR THE STENT PLACEMENT PROCEDURE, IT WAS NOTED THAT THE COATING WAS SHEARED OFF TO THE CORE OF THE HYDROPHILIC WIRE GUIDE. THIS ISSUE WAS PRIOR TO PATIENT CONTACT, ANOTHER DEVICE WAS USED, AND THERE WERE NO ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Information

  MAUDE report 7885643 ↗
• MalfunctionApr 26, 2017Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE USING A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE, THE PHYSICIAN STATES THAT THE COATING WAS COMING OFF ON THE STIFF ANGLED GLIDE WIRE ONCE AGAIN. AT THE TIME OF THIS REPORT, ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6522363 ↗