BentsonRecalls & reported problems across all models
Cook Incorporated · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Bentson model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 2
We found 12 models of Bentson by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2016 and Sep 30, 2026 — classified as 8 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (32 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bentson recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
- 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-1826-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Bentson problems
Device problems
- Unraveled Material32
- Material Separation13
- Material Protrusion/Extrusion6
- Break5
- Material Frayed5
- Flaked4
- Difficult to Remove3
- Peeled/Delaminated3
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient13
- No Consequences Or Impact To Patient9
- Insufficient Information6
- No Code Available3
- No Patient Involvement3
- Foreign Body In Patient2
- Discomfort1
Bentson models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bentson G27041WIRE, GUIDE, CATHETER2 recalls0 reports
- Bentson G00691WIRE, GUIDE, CATHETER1 recall26 reports
- Bentson G01095WIRE, GUIDE, CATHETER1 recall1 report
- Bentson G01290WIRE, GUIDE, CATHETER17 reports
- Bentson G01063WIRE, GUIDE, CATHETER14 reports
- Bentson G00692WIRE, GUIDE, CATHETER3 reports
- Bentson G01062WIRE, GUIDE, CATHETER2 reports
- Bentson G01315WIRE, GUIDE, CATHETER1 report
- Bentson G01431WIRE, GUIDE, CATHETER1 report
- Bentson G01750WIRE, GUIDE, CATHETER1 report
- Bentson G14589Endoscopic guidewire, gastroenterology-urology1 report
- Bentson G14590Endoscopic guidewire, gastroenterology-urology1 report
Recent Bentson adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Flaked
Patient problems: Foreign Body In Patient
MAUDE report 50954409 ↗MalfunctionSep 28, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924307 ↗MalfunctionNov 6, 2025Unraveled Material; Unraveled Material
IT WAS ORIGINALLY REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAPHY PROCEDURE VIA ACCESS THROUGH THE FEMORAL ARTERY WITH A TARGET OF THE SUPERFICIAL FEMORAL ARTERY (FSA), A BENTSON STRAIGHT FIXED CORE WIRE GUIDE BEGAN TO "SWELL" AND GOT STUCK INSIDE ANOTHER MANUFACTURER'S CATHETER. THE CATHETER WAS CUT TO REMOVE THE WIRE GUIDE FROM THE PATIENT. THE PHYSICIAN HAD TO PULL "PRETTY HARD" TO PULL THE WIRE GUIDE OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S WIRE GUIDE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE LEFT INSIDE THE PATIENT. UPON PRELIMINARY EVALUATION OF THE RETURNED DEVICE ON 21OCT2025, THE COIL OF THE WIRE GUIDE WAS FOUND TO BE UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485846 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT THE BENTSON STRAIGHT CEREBRAL FIXED CORE WIRE GUIDE SEPARATED DURING A TUNNELED HD (HEMODIALYSIS) CATHETER PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965155 ↗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 ↗MalfunctionApr 23, 2025Unraveled Material; Unraveled Material
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING TREATMENT OF PERIPHERAL ARTERY DISEASE, A BENTSON STRAIGHT FIXED CORE WIRE GUIDE UNRAVELED AT THE TIP. THE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT, WHO WAS REPORTEDLY NOT AFFECTED AND DOING WELL. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894079 ↗MalfunctionNov 20, 2024Unraveled Material; Unraveled Material
AS REPORTED, PRIOR TO PATIENT CONTACT FOR AN UNKNOWN PROCEDURE, TWO BENTSON STRAIGHT FIXED CORE WIRE GUIDES "SHEARED". 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733802 ↗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 ↗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 ↗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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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