Cook G01304Recalls & 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 00827002013049), received between Sep 25, 2018 and Sep 27, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Entrapment of Device1
- Failure to Advance1
- Stretched1
- Unraveled Material1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2018Unraveled Material
THE COMPLAINANT REPORTED THAT THE TIP ON THE SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE UNRAVELED WHEN THE WIRE WAS PULLED BACK FROM WITHIN THE NEEDLE ON TWO SEPARATE OCCASIONS. THE NEEDLE AND WIRE HAD TO BE REMOVED, AND ANOTHER PUNCTURE WAS PERFORMED USING A DIFFERENT WIRE FOR THE ANGIOPLASTY IN THE PATIENT'S LEFT LEG. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7913906 ↗MalfunctionSep 25, 2018Break; Entrapment of Device; Stretched; Failure to Advance; Detachment of Device or Device Component
THE COMPLAINANT REPORTED THAT THE AFS ANTEGRADE WAS PRICKED AND A SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE WAS INSERTED. THE WIRE GUIDE WOULD NOT ADVANCE TO WHERE IT NEEDED TO BE, AND IT BECAME STUCK HALFWAY THROUGH THE ILIACS. THERE WAS AN ATTEMPT TO RETRIEVE THE WIRE, BUT IT BROKE DURING THE PROCESS AND IT WAS STRETCHED. THE WIRE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS POSTPONED. IT WAS FURTHER NOTED THAT THE WELD CONNECTION DISCONNECTED FROM THE COIL AND SAFETY WIRE WHICH RESULTED IN COIL ELONGATION. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Code Available
MAUDE report 7906992 ↗
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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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