Cook G00507Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Safe-T-J, Curved · Class 2
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.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002005075), received between Nov 20, 2019 and Jul 9, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (2 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-1833-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Frayed2
- Material Protrusion/Extrusion1
- Material Twisted/Bent1
- Peeled/Delaminated1
- Stretched1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent
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 19700462 ↗MalfunctionJun 14, 2023Stretched; Unraveled Material; Material Protrusion/Extrusion; Stretched; Unraveled Material; Material Protrusion/Extrusion
UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS UNRAVELED, AND THE SAFETY WIRE AND MANDRIL PROTRUDED AND WERE EXPOSED. THE WIRE WAS STRETCHED AND ELONGATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17128501 ↗MalfunctionNov 12, 2020Material 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 Consequences Or Impact To Patient
MAUDE report 10828444 ↗MalfunctionNov 20, 2019Material Frayed; Material Frayed
ADDITIONAL INFORMATION RECEIVED 05DEC2019. AS REPORTED, THE DEVICE WAS USED WITH A COOK ULT 7.0 CATHETER. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE. THE PATIENT DID NOT HAVE ANY NOTED VESSEL TORTUOSITY OR CALCIFICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9346902 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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