Cook G00655Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Straight · 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 00827002006553), received between Sep 19, 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
- Material Twisted/Bent1
- Stretched1
Patient problems
- No Consequences Or Impact To 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.
MalfunctionSep 27, 2018Break; Material Twisted/Bent
IT WAS REPORTED THE END OF THE STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE WAS LOOPED ON ITSELF WHEN REMOVED FROM THE PACKAGING, AND IT WAS LATER FOUND THAT THE DISTAL WELD CONNECTION HAD BROKEN. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7914211 ↗MalfunctionSep 19, 2018Entrapment of Device; Stretched; Detachment of Device or Device Component
THE COMPLAINANT REPORTED THAT THE STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE WAS STUCK INSIDE OF ANOTHER MANUFACTURER'S BALLOON DURING PATIENT CONTACT. THE WIRE DID NOT COME APART UNTIL IT WAS OUTSIDE OF THE PATIENT'S BODY. IT WAS FURTHER NOTED THAT THE COIL NEAR THE DISTAL END OF THE WIRE WAS ELONGATED, AND THE DISTAL WELD CONNECTION SEPARATED FROM THE SAFETY WIRE AND COIL TO RESULT IN COIL ELONGATION. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH, AND THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7889750 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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.
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