Bentson Plus G09782Recalls & reported problems
Cook Incorporated · Bentson Plus Wire Guide Extra Body / 20cm Distal Flexibility with Softened Tip · Class 2
All models of Bentson Plus (3)
Data updated Oct 18, 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.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002097827), received between Mar 27, 2018 and Mar 17, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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 18, 2026.
Recalls naming this device
- Aug 16, 2022Class IIOpen, 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-1825-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Fracture1
- Peeled/Delaminated1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Tissue Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2022Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material
AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY AND ATHERECTOMY, THE COATING OF A BENTSON PLUS FIXED CORE WIRE GUIDE CAME OFF OF THE DEVICE. THE DEVICE WAS ADVANCED VIA ANTEGRADE APPROACH FROM THE GROIN DOWN THE SUPERFICIAL FEMORAL ARTERY TO THE PEDAL ARTERY. ANOTHER MANUFACTURER'S CATHETER WAS ADVANCED OVER THE WIRE, AND THE WIRE WAS ATTEMPTED TO BE REMOVED TO EXCHANGE FOR A CROSSING WIRE. WHEN REMOVING THE WIRE, COATING WAS NOTED TO HAVE SCRAPED OFF A SMALL SECTION OF THE DISTAL END OF THE WIRE, AND THE TIP INTEGRITY WAS DEGRADED. THE WIRE WAS DIFFICULT TO REMOVE FROM THE CATHETER. A SMALL AMOUNT OF THROMBUS WAS PULLED BY THE WIRE. THE WIRE WAS EVENTUALLY ABLE TO BE COMPLETELY REMOVED FROM THE CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13790733 ↗MalfunctionMar 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
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 8459891 ↗MalfunctionMar 27, 2018Fracture; Fracture
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WHEN REMOVING THE BENTSON PLUS FIXED CORE WIRE GUIDE FROM ITS PROTECTIVE HOLDER, THE PHYSICIAN'S GLOVE AND HAND WERE CUT BY A BARB ON THE WIRE. THE BARB WAS LOCATED NEAR THE TRANSITION OF THE STIFF WIRE TO THE FLEXIBLE END. THE PHYSICIAN CLEANED UP THE WOUND AND BANDAGED IT TO CONTINUE THE SCHEDULED PROCEDURE. THE PHYSICIAN DID NOT REQUIRE ANY PROCEDURE/ INTERVENTION DUE TO THIS OCCURRENCE.
Patient problems: Tissue Damage
MAUDE report 7373325 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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