Cook G00524Recalls & 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002005242), received between May 16, 2016 and May 8, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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.
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Difficult to Remove1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
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 8590891 ↗InjuryMay 16, 2016Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
THE PATIENT WAS HAVING THEIR ANNUAL CECOSTOMY TUBE CHANGED. A CECOSTOMY TUBE WAS PLACED OVER GUIDEWIRE IN PATIENT. THE GUIDEWIRE GOT STUCK UPON REMOVAL AND UNRAVELED. THERE MAY HAVE BEEN SOME WIRE LEFT IN THE BODY. THE USER ENDED UP CUTTING THE CECOSTOMY TUBE ALONG WITH THE STUCK GUIDEWIRE AND THREAD A NEW GUIDEWIRE INSIDE, RESULTING IN HAVING TO RE-DO THE PROCEDURE WITH A NEW CECOSTOMY AND GUIDEWIRE.
Patient problems: Foreign Body In Patient
MAUDE report 5656625 ↗
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page