Traxcess 7 Mini GW0721006MRecalls & reported problems
Microvention, Inc. · Guidewires · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777025494), received between Jul 23, 2017 and Jul 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
1 other recall cover devices cleared under the same FDA submission (K161803); they may or may not involve this specific model.
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
Device problems
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2017Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAXCESS GUIDEWIRE WAS REMOVED FROM THE PATIENT TO RE-SHAPE THE TIP. PRIOR TO RE-USE IN THE PATIENT, THE INSERTION TOOL WAS BACKLOADED ONTO THE GUIDEWIRE AND DURING THE PROCESS, THE COATING APPEARED TO STRIP OFF THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6735039 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161803. One submission often covers many models, so check the product and lot details in each record.
- Z-3103-2017 · Aug 7, 2017 · TerminatedMicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- 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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