Bentson G01062Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002010628), received between Dec 7, 2016 and Sep 24, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 Frayed1
- Material Separation1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2018Material Frayed
IT WAS REPORTED THAT A BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE WAS BEING USED FOR AN ANGIOGRAM AND BALLOON ANGIOPLASTY PROCEDURE. ENTRY WAS MADE THROUGH THE RIGHT FEMORAL ARTERY, AND THE DEVICE WAS ADVANCED THROUGH THE LEFT ILIAC ARTERY, FEMORAL ARTERY, AND SUPERFICIAL FEMORAL ARTERY. DURING REMOVAL OF THE WIRE, IT WAS FOUND TO BE FRAYED APPROXIMATELY 2.5IN FROM THE TIP. THE PROCEDURE WAS CONTINUED WITH ANOTHER WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7902447 ↗InjuryDec 7, 2016Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent
IT WAS REPORTED DURING A LOWER EXTREMITY ARTERIOGRAM PROCEDURE ON A (B)(6) YEAR OLD FEMALE PATIENT, THE GUIDE WIRE BROKE OFF INSIDE THE CATHETER. THE FACILITY HAD TO SNARE THE BROKEN PORTION TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE FROM THE PATIENT¿S ANATOMY. ANOTHER DEVICE FROM AN UNKNOWN MANUFACTURER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 6151894 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page