Cook G00509Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Safe-T-J, Curved · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002005099), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unraveled Material” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1833-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2025Unraveled Material; Unraveled Material
AS REPORTED, DURING A PROCEDURE TO EXCHANGE A PRE-EXISTING NEPHROSTOMY TUBE, A SAFE-T-J FIXED CORE WIRE GUIDE UNRAVELED. THE WIRE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS NOT PULLED OR MANIPULATED THROUGH A METAL INSTRUMENT. THERE WAS AN ESTABLISHED TRACK TO THE KIDNEY DUE TO PREVIOUS PLACEMENT OF A NEPHROSTOMY TUBE. THE WIRE WAS REPORTEDLY PLACED INSIDE THE KIDNEY, WITHOUT ENCOUNTERING RESISTANCE, AND THE NEPHROSTOMY TUBE WAS REMOVED OVER THE WIRE. A NEW NEPHROSTOMY TUBE WAS THEN PLACED IN THE KIDNEY. AS THE RADIOLOGIST ATTEMPTED TO REMOVE THE WIRE, IT COULD NOT BE REMOVED, AS THE WIRE WAS UNRAVELED AND STUCK ON THE END OF THE NEPHROSTOMY TUBE. THE PHYSICIAN THEN REMOVED THE WIRE AND NEPHROSTOMY TUBE FROM THE PATIENT AT THE SAME TIME. THE USER WAS UNABLE TO RE-GAIN ACCESS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND BECAUSE THE RADIOLOGIST WAS UNABLE TO RE-GAIN ACCESS, A PERCUTANEOUS PROCEDURE WAS PERFORMED TO INSERT A NEW NEPHROSTOMY TUBE. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292793 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 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