Bentson G00691Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Cook Bentson wire guide is used to help place medical devices during procedures. Its 25 reports mostly describe the wire unraveling, separating, stretching, or losing its coating; 3 injuries and no deaths were reported. The device has 1 open recall, begun in August 2022, because a packaging seal may be fully breached, potentially compromising sterility.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002006911), received between Mar 24, 2016 and Sep 30, 2026 — classified as 4 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (11 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1827-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Unraveled Material11
- Flaked4
- Material Separation4
- Break2
- Difficult to Remove2
- Material Frayed2
- Material Protrusion/Extrusion2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information3
- No Code Available3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Discomfort1
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Flaked
Patient problems: Foreign Body In Patient
MAUDE report 50954409 ↗MalfunctionAug 12, 2024Unraveled Material; Unraveled Material
AS ORIGINALLY REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS NOT IN ITS ¿SAFETY NEST¿ PACKAGING. UPON RETURN OF THE COMPLAINT DEVICE ON 31JUL2024, THE GUIDEWIRE WAS ELONGATED/STRETCHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. 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 19966771 ↗MalfunctionApr 11, 2024Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING AN UNSPECIFIED CORONARY PROCEDURE, THE DISTAL PORTION OF A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED AND SEPARATED. ANOTHER TYPE OF COOK 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 DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087529 ↗MalfunctionJan 11, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 19JAN2024. THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL STATE AND IT WAS NOT MANIPULATED OR REMOVED THROUGH A NEEDLE OR OTHER METAL INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 18495896 ↗MalfunctionJan 11, 2024Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove
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 18494968 ↗MalfunctionJan 11, 2024Peeled/Delaminated; Difficult to Remove; Stretched; Peeled/Delaminated; Difficult to Remove; Stretched
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE COATING CAME OFF OF A BENTSON STRAIGHT FIXED CORE WIRE GUIDE. REPORTEDLY, UPON EXTRACTION OF THE WIRE, RESISTANCE WAS ENCOUNTERED AND THE USER STRUGGLED TO REMOVE THE WIRE. UPON REMOVAL, THE USER NOTED THAT THE COATING HAD COME OFF THE WIRE, WITH ONE CENTIMETER OF THE COATING VISIBLY MISSING. THE WIRE WAS NOT ALTERED PRIOR TO USE. IT IS UNKNOWN IF ANY OF THE COATING REMAINED IN THE PATIENT; HOWEVER, 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 18494638 ↗MalfunctionJan 9, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 08FEB2024. THE WIRE WAS NOT ALTERED PRIOR TO USE. ACCESS WAS OBTAINED IN THE JUGULAR VEIN, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION. THE ANATOMY WAS NOT STENOSED, TORTUOUS, CALCIFIED, OR SCARRED. DURING REMOVAL OF THE WIRE, IT BECAME STUCK AND STRETCHED; HOWEVER, THE WIRE DID NOT SEPARATE. THE WIRE WAS NOT MANIPULATED OR PULLED BACKWARDS THROUGH ANY METAL INSTRUMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18479696 ↗MalfunctionJan 9, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 08FEB2024, STATING THAT THE WIRE DID NOT SEPARATE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18479687 ↗MalfunctionOct 26, 2023Unraveled 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18011872 ↗MalfunctionOct 26, 2023Unraveled 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18011825 ↗MalfunctionOct 26, 2023Unraveled 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18011468 ↗MalfunctionOct 2, 2023Break; Break
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 17856644 ↗MalfunctionAug 9, 2023Flaked; Flaked
AS ORIGINALLY REPORTED, PRIOR TO USE FOR A RADIAL "UFE" PROCEDURE, THE COATING WAS MISSING FROM A BENT BENTSON STRAIGHT FIXED CORE WIRE GUIDE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE, FROM THE SAME LOT, WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THAT THE COATING LIKELY FLAKED/ CAME OFF THE DEVICE AT THE BENT AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492156 ↗MalfunctionApr 7, 2023Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
AS REPORTED, PRIOR TO PATIENT CONTACT, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNCOILED NEAR THE DISTAL END. ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16700811 ↗MalfunctionMar 22, 2023Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS FOUND AT THE DISTRIBUTION FACILITY WITH OPEN PACKAGING DUE TO "POOR ADHESION". THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16589664 ↗MalfunctionMay 27, 2021Material Frayed; Material Frayed
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893545 ↗MalfunctionOct 22, 2020Material 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 10717684 ↗InjuryApr 27, 2020Material 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 Code Available
MAUDE report 10002233 ↗MalfunctionNov 12, 2019Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9310881 ↗MalfunctionJan 7, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE'S INNER WIRE WAS EXPOSED. IT WAS REPORTED THAT "THE OUTER WRAP ON THE WIRE PULLED APART FROM THE INNER WIRE". THIS WAS OBSERVED AFTER THE WIRE WAS REMOVED FROM THE PATIENT. THE WIRE DID NOT COMPLETELY SEPARATE OR DETACH INTO PORTIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW WIRE. IT WAS REPORTED THAT THE SAME EVENT OCCURRED "ONE TIME EACH DURING TWO CONSECUTIVE PROCEDURES". THE SECOND EVENT IS CAPTURED UNDER MDR 1820334-2019-00068. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8221933 ↗MalfunctionJan 7, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE'S INNER WIRE WAS EXPOSED. IT WAS REPORTED THAT "THE OUTER WRAP ON THE WIRE PULLED APART FROM THE INNER WIRE". THIS WAS OBSERVED AFTER THE WIRE WAS REMOVED FROM THE PATIENT. THE WIRE DID NOT COMPLETELY SEPARATE OR DETACH INTO PORTIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW WIRE. IT WAS REPORTED THAT THE SAME EVENT OCCURRED "ONE TIME EACH DURING TWO CONSECUTIVE PROCEDURES". THE SECOND EVENT IS CAPTURED UNDER MDR 1820334-2019-00069. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8221920 ↗MalfunctionSep 24, 2018Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE HAD ITS INNER MANDRIL PROTRUDING FROM THE COIL, CAUSING DISCOMFORT WHEN INSERTED INTO THE PATIENT DURING A BILIARY PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: Discomfort
MAUDE report 7902075 ↗MalfunctionSep 21, 2018Failure to Advance
THE COMPLAINANT REPORTED THAT THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE WOULD NOT ADVANCE IN THE SHEATH. THE WIRE COATING WAS REPORTEDLY STRIPPED FROM THE WIRE GUIDE, SO ANOTHER DEVICE WAS USED TO COMPLETE THE LOWER EXTREMITY ARTERIOGRAM. IT WAS FURTHER NOTED THAT THERE WAS COIL ELONGATION NEAR THE DISTAL END OF THE DEVICE, AND SEPARATION OF THE DISTAL WELD CONNECTION FROM THE SAFETY WIRE AND COIL. THIS PRODUCT ISSUE OCCURRED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED IMPACT ON THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7897916 ↗MalfunctionNov 27, 2017Fracture; Fracture
IT WAS REPORTED THAT DURING A DRAINAGE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE INSERTING THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE AND NOTICED THAT IT WAS BROKEN INTO TWO PORTIONS AT THE DISTAL PART. THE WIRE GUIDE WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT WITH THE PIGTAIL DRAINAGE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW GUIDE WIRE AND CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7061256 ↗InjuryMar 25, 2016Flaked; Unraveled Material; Flaked; Unraveled Material
DURING A URETEROSCOPY PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER, THE OUTER LAYER (GREEN) UNRAVELED EXPOSING THE METAL WIRE INSIDE. THE COATING THAT UNRAVELED WAS REMOVED SUCCESSFULLY WITH NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 5526103 ↗
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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 · each recall links to the FDA recall notice
- 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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