Traxcess Guidewire GW1420040Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00810170012280), received between Nov 10, 2017 and Apr 18, 2025 — classified as 11 injuries, 20 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE CASE WAS BEING PERFORMED BY 2 EXPERIENCED INTERVENTIONISTS. THE TRAXCESS WIRE WAS USED TO DELIVER A MICROCATHETER INTO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE CATHETER WAS PLACED AND THE MICROWIRE WAS REMOVED. WHEN THE OPERATOR TRIED TO PLACE THE STENT INTO THE MICROCATHETER THERE WAS SIGNIFICANT RESISTANCE, AND THE STENT WAS UNABLE TO BE TRACKED FORWARD TO THE CATHETER TIP. THE USERS THEN INVESTIGATED THE DEVICES THAT THEY HAD BEEN USING AND IDENTIFIED SOME IRREGULARITIES ALONG THE LENGTH OF THE TRAXCESS WIRE, WHICH THEY IDENTIFIED AS STRIPPING OF THE HYDROPHILIC COATING. AN ASSUMPTION WAS MADE THAT PARTS OF THIS COATING WERE LODGED IN THE MICROCATHETER IMPEDING THE DELIVERY OF THE STENT. A SECONDARY WIRE (STRYKER SYNCHRO SELECT) WAS USED TO RE CANNULATE AND A NEW MICROCATHETER AND STENT WAS USED TO SUCCESSFULLY TO COMPLETE THE CASE. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869637 ↗
• MalfunctionMar 27, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE DEVICE PREPARATION PRIOR TO USE, THE NURSE PREPARED AND TESTED THE GUIDEWIRE BY INSERTING IT INTO THE INTRODUCER AND FOUND THAT SOME PARTS HAD COME LOOSE. SO, THE GUIDEWIRE HAD TO BE REPLACED. IT WAS SUSPECTED THAT THE MICRO GUIDEWIRE COATING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708254 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE MODEL AND LOT NUMBER RECEIVED. NO FURTHER INCIDENT INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21185890 ↗
• MalfunctionJan 7, 2025Missing Information; Missing Information

  AS REPORTED BY THE DISTRIBUTOR: 1 UNIT WITHOUT PRODUCT IDENTIFICATION IN DIFFERENT LANGUAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095357 ↗
• InjuryDec 30, 2024Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED THAT STATED THE PATIENT'S ANATOMY WAS TORTUOUS WHICH MADE IT DIFFICULT TO REMOVE AND IT BROKE. THE PATIENT'S CONDITION REMAINS THE SAME AS STROKE SCALE OF NIHSS 20. NO FURTHER INFORMATION IS AVAILABLE FOR THIS CASE.

  Patient problems: Stroke/CVA

  MAUDE report 21044512 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED, WHICH PROVIDED TWO RADIOGRAPHIC IMAGES.

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 20649584 ↗
• MalfunctionJul 3, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE CEREBRAL EMBOLIZATION PROCEDURE, THE DEVICE PRESENTED STRETCHING/DISTENSION IN ITS WIRE, MAKING IT IMPOSSIBLE TO USE, AND WAS REPLACED BY ANOTHER. PROCEDURE COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS OR PROBLEMS WITH THE PATIENT. PATIENT OUTCOME WAS DESCRIBED AS "GREAT." THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT AS THE ISSUE WAS NOTICED DURING PREPPING. HOWEVER, UPON EVALUATION OF THE RETURNED GUIDEWIRE, PEELING OF THE PTFE COATING AT THE DISTAL END WAS NOTED. (REFER TO SECTION H11 FOR DEVICE EVALUATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669044 ↗
• MalfunctionJun 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE GUIDEWIRE WAS USED IN MECHANICAL THROMBECTOMY PROCEDURE. DURING PREPARATION AND UPON REMOVING THE GUIDEWIRE FROM THE PLASTIC SHEATH, IT WAS NOTED THAT THE GUIDEWIRE IS NICKED. THERE WAS NO PATIENT INVOLVEMENT AND GUIDEWIRE WAS NOT USED AND WAS RETURNED BACK INTO THE SHEATH. AFTER THE PROCEDURE THE PATIENT WAS RECOVERING, LIFTING THE LIMBS IN ANTIGRAVITATIONAL TEST. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT; HOWEVER, UPON EVALUATION OF THE RETURNED GUIDEWIRE, PEELING OF THE PTFE COATING AT THE DISTAL END WAS NOTED. (REFER TO SECTION H11 FOR DEVICE EVALUATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620061 ↗
• MalfunctionMay 9, 2024Contamination; Contamination

  AS REPORTED: THE INR TEAM DISCOVERED, BEFORE THE PROCEDURE, A THREAD LIKE FOREIGN BODY ON THE WIRE. THE WIRE HAD NOT BEEN IN TOUCH WITH ANYTHING BEFORE THIS WAS DISCOVERED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280712 ↗
• MalfunctionMay 9, 2024Contamination; Contamination

  AS REPORTED: THE INR TEAM DISCOVERED, BEFORE THE PROCEDURE, A THREAD LIKE FOREIGN BODY ON THE WIRE. THE WIRE HAD NOT BEEN IN TOUCH WITH ANYTHING BEFORE THIS WAS DISCOVERED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280696 ↗
• MalfunctionApr 11, 2024Flaked; Flaked

  AS REPORTED: WEB PROCEDURE, AFTER ESTABLISHING THE PATHWAY, GUIDEWIRE WITH VIA TO THE M2 IN THE BRAIN, CARRIED OUT SUPERSELECTION INTO THE ANEURYSM, AFTER SEVERAL TIMES WITHOUT SUCCESS, READY TO REMOVE AND REMODEL. AFTER THE REMOVED, THE PHYSICIAN FOUND THAT THE CLEAN WATER COATING ON THE SURFACE OF THE GUIDE WIRE FELL AND REPLACED IT WITH A NEW ONE. THE PROCEDURE ENDED AND THE PATIENT WAS SAFELY. PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086941 ↗
• MalfunctionNov 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED. THIS REPORT REPRESENTS CORRECTIONS TO A PREVIOUSLY SUBMITTED MDR. FIELDS CORRECTED (UDI RELATED DATA QUALITY UPDATES ) ARE LISTED IN H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193873 ↗
• InjuryMar 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AS THE COIL WAS BEING PLACED IN A PATIENT, IT WAS DETERMINED TO NOT BE IN THE CORRECT POSITION FOR DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE; HOWEVER, WHILE REMOVING THE DEVICE, THE COIL BECOME DETACHED, OR STRETCHED TO THE POINT THAT THE COIL WAS NOT SUCCESSFULLY REMOVED FROM THE BODY AND REMAINED IN THE COIL MASS WITH A "TAIL" IN THE PATIENT¿S NATIVE ANATOMY. THE COIL AND THE DELIVERY CATHETER WERE REMOVED. THE PHYSICIAN WENT TO CROSS THE ANEURYSM NECK WITH A TRAXCESS WIRE; HOWEVER, IT SUBSEQUENTLY GOT STUCK SOMEWHERE WITHIN THE PRIOR STENT OR COIL TAIL. THIS WIRE WAS THEN TWISTED UNTIL THE DISTAL TIP BROKE OFF AND REMAINED IN THE PATIENT, THE REMAINDER OF THE WIRE WAS REMOVED. THE COIL WAS REPORTED TO BE IN THE PARENT ARTERY POST PROCEDURE; THUS, INTERVENTION WITH A STENT WAS PERFORMED. THE PATIENT WAS REPORTED TO BE DOING GOOD. THIS REPORT ADDRESSED THE GUIDE WIRE USED IN THE CASE WITH COIL REPORTED IN MFR# 2032493-2023-00592.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474815 ↗
• MalfunctionAug 5, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT AFTER SHAPING THE GUIDEWIRE, THE CODING ON THE TIP APPEARED DIFFERENT. A NEW TRAXCESS GUIDEWIRE WAS SHAPED AND USED WITHOUT ANY PROBLEMS. THE ISSUE WAS IDENTIFIED DURING PREP, AND THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180373 ↗
• MalfunctionAug 4, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE TIP OF THE TRAXCESS WAS DEFORMED. CLARIFICATION NOTED IT SEEMED THAT THE COATING WAS UNEVEN OR INADEQUATE AND DAMAGED IN THE FIRST FEW CENTIMETERS. A NEW TRAXCESS WAS USED. THERE WAS NO REPORTED IMPACT OR HARM TO THE PATIENT. THE REPORTER HAS NO OTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164182 ↗
• MalfunctionJul 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TREATMENT OF A STROKE ON A LEFT MEDIA ARTERY, A SECOND AND THIRD PASS WERE NECESSARY TO CATCH THE CLOT. DURING THE PREPARATION OF THE TRAXCESS FOR THE SECOND PASS, SMALL STRINGS WERE VISIBLE AT THE FLEXIBLE TIP OF THE WIRE. PRIOR TO THE THIRD PASS MORE STRINGS WERE OBSERVED AT THE TIP. IT WAS REPORTED THAT A METAL INTRODUCER WAS USED FOR ADVANCING THE TRAXCESS INTO THE HUB OF THE MICROCATHETER. THE TRAXCESS WAS EXCHANGED TO ANOTHER TRAXCESS WIRE AND THE EXAMINATION WAS FINISHED. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973899 ↗
• MalfunctionMar 23, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM ON THE LEFT ICA, A TRAXCESS SOFT GUIDEWIRE WAS CHOSEN FOR CANNULATING THE ANEURYSM. THE PHYSICIAN OBSERVED SOME KIND OF MATERIAL ON THE SURFACE WHEN THE TRAXCESS GUIDEWIRE WAS PULLED OUT OF THE MICROCATHETER. PHYSICIAN HAD THE IMPRESSION THAT THE HYDROPHILIC COATING SHEERED OFF FROM THE GUIDEWIRE BODY. THE GUIDEWIRE WAS EXCHANGED FOR ANOTHER TRAXCESS SOFT AND PROCEDURE CONTINUED WITH GOOD RESULT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT, WHO WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862597 ↗
• InjuryOct 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT WHO HAD A COILING PROCEDURE PERFORMED LATER DEVELOPED FOREIGN BODY RELATED VASCULITIS SOME MONTHS AFTER THE PROCEDURE. FILAMENTOUS COMPONENTS FROM FOREIGN OBJECTS COULD BE VERIFIED, BUT NOT THE REAL ORIGIN; A TRAXCESS GUIDEWIRE WAS ONE OF MANY DEVICES USED DURING THE PROCEDURE. IT WAS STATED THAT THE FILAMENTOUS COMPONENTS SHOWED "BASOPHIL CHARACTERISTICS" AND A CASUAL RELATIONSHIP BETWEEN THE VASCULITIS AND THE TRAXCESS COULD NOT BE VERIFIED. THE PATIENT IS REPORTED TO BE DOING "OK."

  Patient problems: Inflammation

  MAUDE report 12584565 ↗
• InjurySep 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PREOPERATIVE EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA PROCEDURE, THE PHYSICIAN NOTED A BARELY VISIBLE TRANSPARENT FILAMENTOUS FRAGMENT OF APPROXIMATELY 5 CM LENGTH, ALLEGEDLY STEMMING FROM THE TRAXCESS MICROGUIDEWIRE COATING. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROGUIDEWIRE OF UNKNOWN MODEL WITHOUT ANY DIFFICULTIES. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448851 ↗
• InjurySep 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PREOPERATIVE EMBOLIZATION OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA PROCEDURE, THE PHYSICIAN NOTED FRAGMENTS OF POLYTETRAFLUOROETHYLENE AND SILICONE OIL, ALLEGEDLY STEMMING FROM THE TRAXCESS MICROGUIDEWIRE COATING. MICROCATHETER NAVIGATION WAS PERFORMED OVER THE 0.01400 TRAXCESS 14 AND 0.01400 MICROGUIDEWIRE FROM ANOTHER MANUFACTURER. DURING A RESHAPING MANEUVER OF THE TRAXCESS MICROGUIDEWIRE, MULTIPLE BLUE COLORED FRAGMENTS OF 1-2 MM IN DIAMETER WERE NOTICED HANGING FROM ITS TIP AS WELL AS IN THE BOWL WITH STERILE SALINE USED FOR WETTING MICROGUIDEWIRES AND CATHETERS. THE PROCEDURE WAS THEN HALTED AND THE GUIDEWIRE WAS INSPECTED WITH NO OBVIOUS SIGNS OF SURFACE DAMAGE. AFTER CHANGING MICROCATHETER AND MICROGUIDEWIRE THE PROCEDURE WAS CONTINUED. HOWEVER, SHORTLY AFTER INTRODUCING A NEWLY OPENED TRAXCESS MICROGUIDEWIRE, ANOTHER BLUE FILAMENTOUS FRAGMENT WAS NOTED THAT APPEARED TO BE CREATED NEAR THE TIP OF THE INTRODUCER. THE PROCEDURE WAS HALTED AGAIN AND CONTINUED USING OTHER MANUFACTURER MICROGUIDEWIRE WITH NO OTHER OBVIOUS FRAGMENTS BEING OBSERVED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448241 ↗
• InjurySep 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PREOPERATIVE EMBOLIZATION OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA PROCEDURE, THE PHYSICIAN NOTED FRAGMENTS OF POLYTETRAFLUOROETHYLENE AND SILICONE OIL, ALLEGEDLY STEMMING FROM THE TRAXCESS MICROGUIDEWIRE COATING. MICROCATHETER NAVIGATION WAS PERFORMED OVER THE 0.01400 TRAXCESS 14 AND 0.01400 MICROGUIDEWIRE FROM ANOTHER MANUFACTURER. DURING A RESHAPING MANEUVER OF THE TRAXCESS MICROGUIDEWIRE, MULTIPLE BLUE COLORED FRAGMENTS OF 1-2 MM IN DIAMETER WERE NOTICED HANGING FROM ITS TIP AS WELL AS IN THE BOWL WITH STERILE SALINE USED FOR WETTING MICROGUIDEWIRES AND CATHETERS. THE PROCEDURE WAS THEN HALTED AND THE GUIDEWIRE WAS INSPECTED WITH NO OBVIOUS SIGNS OF SURFACE DAMAGE. AFTER CHANGING MICROCATHETER AND MICROGUIDEWIRE THE PROCEDURE WAS CONTINUED. HOWEVER, SHORTLY AFTER INTRODUCING A NEWLY OPENED TRAXCESS MICROGUIDEWIRE, ANOTHER BLUE FILAMENTOUS FRAGMENT WAS NOTED THAT APPEARED TO BE CREATED NEAR THE TIP OF THE INTRODUCER. THE PROCEDURE WAS HALTED AGAIN AND CONTINUED USING OTHER MANUFACTURER MICROGUIDEWIRE WITH NO OTHER OBVIOUS FRAGMENTS BEING OBSERVED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448122 ↗
• InjurySep 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN NOTED FRAGMENTS OF POLYTETRAFLUOROETHYLENE AND SILICONE OIL, ALLEGEDLY STEMMING FROM THE TRAXCESS MICROGUIDEWIRE COATING. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448017 ↗
• MalfunctionNov 13, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE COATING APPEARED TO BE COMING OFF THE GUIDE WIRE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840774 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PASSAGE OF THE GUIDE WIRE THROUGH A P1 OCCLUSION, THERE WAS A POSSIBLE WIRE PERFORATION OF A THALAMOPERFORATING BRANCH PROXIMALLY AT THE LEVEL OF THE OCCLUSION. THERE WAS NO REPORTED ADDITIONAL INTERVENTION OR SEQUELA.

  Patient problems: Perforation of Vessels

  MAUDE report 10439786 ↗
• MalfunctionJun 3, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER REMOVAL FROM THE PACKAGE, THE GUIDE WIRE APPEARED TO BE DELAMINATED. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10117086 ↗