Bentson G00692Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002006928), received between Jul 13, 2016 and Nov 20, 2017 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Separation1
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient2
- Fistula1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2017Unraveled Material; Unraveled Material
IT WAS REPORTED THAT DURING REMOVAL OF THE BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE FROM ANOTHER MANUFACTURER'S BALLOON CATHETER, THE WIRE GUIDE BECAME STUCK AND UNRAVELED. THE ACCESS SITE UTILIZED DURING THE PROCEDURE WAS A DIALYSIS GRAFT. 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: No Known Impact Or Consequence To Patient
MAUDE report 7046749 ↗MalfunctionJun 20, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING A DRAINAGE CATHETER PLACEMENT AS TREATMENT FOR ASCITES, USING A BENTSON STRAIGHT HEPARIN COATED FIXED CORE WIRE GUIDE THE NEW WIRE WAS NOTICED TO BE BROKEN/UNRAVELED/SEPARATED WHEN REMOVING THE WIRE. ADDITIONAL DEVICES USED DURING THE PROCEDURE WERE - CHEEBA NEEDLE AND DILATOR. NO INFORMATION ABOUT THE PATIENT'S ANATOMY WAS AVAILABLE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL TREATMENT, INTERVENTION OR MEDICATIONS. THE PROCEDURE WAS COMPLETED WITH NEW PRODUCTS. THERE WAS NO ADVERSE EVENT OR INJURY TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6654499 ↗InjuryJul 13, 2016Break; Break
DURING A LOWER EXTREMITY ATHERECTOMY PROCEDURE, WHEN THE COOK GUIDE WIRE WAS REMOVED FROM THE PATIENT, THE USER FOUND THAT THE WIRE HAD BROKEN. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAD DEVELOPED AN AV FISTULA OF SFA DURING THE ATHERECTOMY PROCEDURE. A STENT GRAFT WAS PLACED IN THE PATIENT DURING PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT.
Patient problems: Fistula
MAUDE report 5792074 ↗
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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