Bentson G01290Recalls & 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
- 17
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002012905), received between Sep 26, 2018 and Sep 28, 2026 — classified as 1 injury, 16 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (11 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material11
- Material Protrusion/Extrusion3
- Material Separation3
- Break1
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
- Entrapment of Device1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient4
- Insufficient Information1
- No Patient Involvement1
- Perforation of Vessels1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924307 ↗MalfunctionAug 18, 2025Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING A FISTULA, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED/BROKE UPON REMOVAL OF THE DEVICE. THE ANATOMY WAS STENOSED. THE WIRE WAS NOT ALTERED PRIOR TO USE. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22832175 ↗MalfunctionJul 16, 2025Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE INVOLVING INSERTION OF A TUNNELED CATHETER ON THE LEFT SIDE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE "SHEARED OFF". THE WIRE WAS NOT ALTERED PRIOR TO USE. PER THE REPORTER, THERE WAS NO ISSUE INSERTING THE WIRE; HOWEVER, THE USER FELT "SOME" RESISTANCE. WHEN THE PHYSICIAN PULLED THE WIRE OUT OF THE CATHETER, THE OUTSIDE OF THE WIRE "SHEARD OFF". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523556 ↗MalfunctionNov 19, 2024Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722506 ↗MalfunctionOct 1, 2024Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
THE COMPLAINT DEVICES WERE RETURNED TO COOK ON 07OCT2024. ONE WIRE WAS ELONGATED WITH MANDRIL PROTRUSION. THE OTHER WIRE WAS ELONGATED; HOWEVER, MANDRIL PROTRUSION WAS NOT NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344149 ↗MalfunctionSep 10, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 11SEP2024. THE ACCESS SITE IS "TYPICALLY" THE RIGHT GROIN, AND THE WIRE WAS USED WITH ANOTHER MANUFACTURER'S CATHETER. THE PATIENT'S ANATOMY WAS NOT STENOSED, TORTUOUS, CALCIFIED, OR SCARRED. RESISTANCE WAS NOT FELT DURING INSERTION AND THE WIRE WAS NOT MANIPULATED BACKWARD THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179475 ↗MalfunctionSep 10, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 11SEP2024. THE ACCESS SITE IS "TYPICALLY" THE RIGHT GROIN, AND THE WIRE WAS USED WITH ANOTHER MANUFACTURER'S CATHETER. THE PATIENT'S ANATOMY WAS NOT STENOSED, TORTUOUS, CALCIFIED, OR SCARRED. RESISTANCE WAS NOT FELT DURING INSERTION AND THE WIRE WAS NOT MANIPULATED BACKWARD THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179473 ↗MalfunctionJun 4, 2024Unraveled Material; Unraveled Material
IT WAS REPORTED TO COOK THAT TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES UNRAVELED. DURING REMOVAL, WHEN THE CLINICIAN PULLED THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE BACK TO STRAIGHTEN OUT THE TIP, THE WIRE GUIDE UNRAVELED INSIDE THE ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT WIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458734 ↗MalfunctionMay 23, 2023Unraveled Material; Unraveled Material
AS ORIGINALLY REPORTED, DURING INSPECTION OF THE WIRE PRIOR TO USE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS NOTED TO BE DAMAGED. THE DEVICE DID NOT MAKE PATIENT CONTACT. THERE WAS NO HARM TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS STRETCHED AND UNRAVELING. DURING PREPARATION FOR THE SAME PROCEDURE, ANOTHER WIRE FROM THE SAME LOT WAS FOUND TO BE UNRAVELED WITH MANDRIL PROTRUSION. THAT HAS BEEN PREVIOUSLY REPORTED UNDER REPORT REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16986953 ↗MalfunctionApr 26, 2023Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16818082 ↗MalfunctionMay 11, 2021Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: Insufficient Information
MAUDE report 11807266 ↗MalfunctionDec 29, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11087098 ↗MalfunctionOct 22, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10717750 ↗MalfunctionSep 9, 2020Unraveled Material; Unraveled Material
AS REPORTED, DURING AN ABSCESS DRAIN PLACEMENT A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED AS THE DEVICE WAS BEING REMOVED. THE WIRE GUIDE HAD BEEN ADVANCED THROUGH THE ABDOMEN THROUGH ANOTHER MANUFACTURERS CATHETER. AS THE WIRE GUIDE WAS BEING REMOVED RESISTANCE WAS FELT AND IT UNRAVELED. THE PROCEDURE HAD TO BE RESTARTED WITH ANOTHER WIRE GUIDE AND CATHETER. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. IT DID NOT RESULT IN ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10509740 ↗MalfunctionJun 6, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674829 ↗InjuryOct 17, 2018Material Deformation; Material Deformation
IT WAS REPORTED, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS BEING UTILIZED DURING AN ANGIOPLASTY PROCEDURE WHEN, UPON REMOVAL FROM THE PATIENT'S ANATOMY THROUGH ANOTHER MANUFACTURER'S SHEATH , IT WAS NOTED TO BE BENT OR KINKED WITH A HAIR-LIKE PIECE OF METAL PROTRUDING ABOUT THREE INCHES FROM THE END OF THE DEVICE. THE CUSTOMER REPORTED THIS WAS AS A RESULT OF A RE-SHEATHING ERROR WHICH WAS DESCRIBED AS A MANEUVER TO RE-FORM THE TIP MAKING IT STIFF INSTEAD OF FLOPPY. THE METAL PROTRUSION REPORTEDLY PIERCED THE PATIENT'S VESSEL CAUSING THE CONTRAST MATERIAL TO LEAK OUT THE SIDE INTO THE TISSUE. NO MEDICAL INTERVENTION WAS REPORTED. 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. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. IT WAS DISCARDED AT THE FACILITY.
Patient problems: Perforation of Vessels
MAUDE report 7976603 ↗MalfunctionSep 26, 2018Break; Entrapment of Device; Detachment of Device or Device Component
THE COMPLAINANT REPORTED THAT THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE GOT STUCK INSIDE THE CATHETER. IT WAS FURTHER NOTED THAT THE WIRE WAS BROKEN, AND THE DISTAL SOLDER TIP OF THE WIRE WAS DISCONNECTED FROM THE WIRE. THIS ISSUE OCCURRED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED PROCEDURAL IMPACT.
Patient problems: No Patient Involvement
MAUDE report 7910757 ↗
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- 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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