Cook G02273Recalls & reported problems
Cook Incorporated · Double Flexible Tipped Wire Guide · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002022737), received between Feb 4, 2020 and Feb 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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
- Unraveled Material1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2020Unraveled Material; Unraveled Material
IT WAS REPORTED THAT A STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE UNRAVELED WHILE INSIDE THE PATIENT. AN (B)(6) YEAR OLD FEMALE PATIENT WAS INITIALLY ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AFTER A ROBOTIC ASSISTED LEFT LOWER LOBECTOMY WITH A LYMPH NODE BIOPSY. SHE WAS TRANSFERRED TO A MED SURGICAL BED POST OPERATION. THE CENTRAL LINE WAS PLACED IN THE PATIENT'S LEFT SUBCLAVIAN ON (B)(6) 2020. UPON INSERTION, THE GUIDE WIRE WAS NOT THREADING SMOOTHLY. THE PHYSICIAN PULLED THE WIRE BACK AND FOUND IT TO BE UNRAVELLING. A NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9667454 ↗
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.
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