Bentson G01431Recalls & reported problems
Cook Incorporated · Bentson Wire Guide 20cm Distal Flexibility with Softened Tip · Class 2
All models of Bentson (12)
Data updated Oct 16, 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 00827002014312), received between Jul 3, 2017 and Jul 3, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence 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 3, 2017Material Separation; Material Separation
IT WAS REPORTED THAT AN IVC FILTER PLACEMENT PROCEDURE WAS PERFORMED USING A BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE. THE PIGTAIL CATHETER WHICH WAS FLUSHED WITH 10CC OF SALINE SOLUTION WAS INTRODUCED OVER THE BENTSON WIRE INTO IVC TO TAKE ANGIOGRAM. WHEN ATTEMPTING TO EXCHANGE THE WIRE THROUGH THE CATHETER, THE WIRE GOT STUCK INSIDE THE CATHETER. UPON USE OF FORCE TO RETRIEVE THE WIRE, IT UNCOILED AND THE COATING SEPARATED FROM THE WIRE EXPOSING THE COILED MANDRIL. THE CATHETER AND THE GUIDE WIRE WERE REMOVED TOGETHER. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6684115 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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