Traxcess EX Guidewire GW1420040XRecalls & reported problems
Microvention, Inc. · Guidewires · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810170014864), received between Feb 8, 2022 and Jun 27, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (3 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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated3
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED: PHYSICIAN HAS A PATIENT THAT HAD A TRACEES 14X GUIDEWIRE STUCK IN HIS HEAD AND HAD TO CUT IT OFF AT THE GROIN. PROCEDURE WAS ANEURYSM TREATMENT ON CONTRALATERAL SIDE; ANEURYSM EMBOLIZATION WITH FLOW DIVERTER, THEN COILS (NOT MICROVENTION) AND WAS NOT AN EMBOLIC PROCEDURE (NO INJECTION). PROCEDURE DETAILS INCLUDE IT WAS PART OF A COMPREHENSIVE CASE WITH COILS AND FLOW DIVERTER. THE WIRE WAS USED ONLY AFTER THE TREATMENT TO GAIN ACCESS ACROSS THE ACOMM, APPROXIMATELY 2 HOURS IN, THE WIRE STUCK RIGHT AT ACOMM. IT IS THOUGHT THE GUIDEWIRE POSSIBLY BECAME STUCK IN THE PATIENT¿S HEAD BY SPASM BUT NO RESPONSE TO VASODILATORS AND LIKELY CAUGHT IN A PERFORATOR NEAR ACOMM. IT IS NOTED THERE WAS NO REAL TORTUOSITY INVOLVED IN THE PROCEDURE. DEVICES BEING USED WITH THE TRAXCESS WERE COILS, FLOW DIVERTER AND ASSOCIATED CATHETERS, NO DEVICE DETAILS WERE PROVIDED. PATIENT IS NOTED TO BE STABLE, HOWEVER THE WIRE REMAINS IN THE PATIENT. AT TIME OF THIS REPORT, THERE IS NO INTERVENTION PLANNED TO REMOVE THE WIRE FROM THE PATIENT. THE PATIENT IS NOW HOME. EXACT DATE OF SURGERY IS UNKNOWN, BUT " DR. NOTES HE WAS AWARE 6 MONTHS AGO" (FROM 07JUNE2024). ALTHOUGH REQUESTED, NO OTHER INFOR
Patient problems: Foreign Body In Patient
MAUDE report 19625364 ↗MalfunctionJul 10, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT AFTER HYDRATING THE TRAXCESS, THE GUIDEWIRE WAS INSERTED INTO THE MICROCATHETER FROM THE Y-VALVE, WHICH ENCOUNTERED RESISTANCE AND WAS DIFFICULT TO PUSH. THE PHYSICIAN REPLACED THE MICROCATHETER; HOWEVER, THE ATTEMPT FAILED. THE GUIDEWIRE WAS REPLACED, WHICH WAS REPORTED TO HAVE BEEN VERY SMOOTH. THE PATIENT WAS REPORTED TO BE DOING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17293944 ↗MalfunctionFeb 11, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE DEVICE PREPARATION PRIOR TO USE, THE HYDROPHILIC COATING WAS OBSERVED TO BE PEELING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13518885 ↗MalfunctionFeb 8, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE DEVICE PREPARATION PRIOR TO USE, THE HYDROPHILIC COATING WAS OBSERVED TO BE PEELING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13488164 ↗
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- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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