V-14™ Control Wire™ H74939216918210Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of V-14 Control Wire (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729799245), received between Apr 5, 2019 and Jun 15, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
Device problems
- Fracture2
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2023Fracture; Difficult to Advance; Fracture; Difficult to Advance
IT WAS REPORTED THE GUIDEWIRE BROKE. A V-14 CONTROL WIRE AND CAROTID WALLSTENT WERE SELECTED FOR USE. THE CAROTID WALLSTENT WAS POSITIONED FOR DEPLOYMENT IN THE TARGET LESION. HOWEVER, THE V-14 CONTROL WIRE WAS UNABLE TO ADVANCE AND THEN BROKE. BOTH DEVICES WERE REMOVED TOGETHER, AND NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17137667 ↗MalfunctionApr 5, 2019Fracture; Fracture
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A LONG TAPER 182CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. AFTER THE DEVICE WAS NAVIGATED TO THE LESION AND ATTEMPTED TO ROTATE, IT WAS NOTED THAT THE GUIDEWIRE BROKE INTO TWO PIECES. THE FRACTURE POINT WAS OUTSIDE THE PATIENT'S BODY. THE BROKEN PART OF THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8487400 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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