Cook G00541Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002005419), received between Aug 14, 2017 and Sep 18, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Unintended Movement1
Patient problems
- No Information1
- 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.
MalfunctionSep 18, 2017Unintended Movement; Unintended Movement
PATIENT RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO MOTOR VEHICLE ACCIDENT TRAUMA AND HISTORY OF DVT. PATIENT EXPERIENCES DEVICE TILT. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC.
Patient problems: No Information
MAUDE report 6874599 ↗MalfunctionAug 14, 2017Fracture; Fracture
AFTER OPENING A SIMILAR DEVICE FROM THE SAME LOT NUMBER AND FINDING THE "J" CURVE TO BE UNSATISFACTORY, A NEW DEVICE WAS OPENED AND PREPPED FOR THE CATHETERIZATION OF THE LEFT HEART OF AN UNKNOWN PATIENT. HOWEVER, THE DEVICE HAD A CRACK AT THE J TIP AND WAS NOT USED. A THIRD DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THE COMPLAINT DEVICE.
Patient problems: No Patient Involvement
MAUDE report 6792924 ↗
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- 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.
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