Cook G00664Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Straight · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002006645), received between Sep 25, 2018 and Sep 9, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (2 reports).
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-1834-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Unraveled Material2
- Break1
- Detachment of Device or Device Component1
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break
It was reported that a Straight Fixed Core Wire Guide experienced internal wire separation during an unspecified procedure. This occurrence was said to prolong the procedural time; however, the patient did not experience any adverse effects or require any additional procedures.Additional information regarding the event has been requested but is currently unavailable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695029 ↗MalfunctionAug 28, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, IT WAS REPORTED THAT THE WIRE WAS NOT MANIPULATED OR SHAPED PRIOR TO INSERTION. THE WIRE WAS WITHDRAWN THROUGH THE CATHETER. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE NEPHROSTOMY TUBE EXCHANGE WAS COMPLETED. THE WIRE WAS REMOVED INTACT BUT WAS IN A COMPROMISED CONDITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22913130 ↗MalfunctionJan 4, 2022Material Separation; Unraveled Material; Device Damaged Prior to Use; Material Separation; Unraveled Material; Device Damaged Prior to Use
IT WAS REPORTED THAT A STRAIGHT FIXED CORE WIRE GUIDE WAS FOUND TO BE UNRAVELLED UPON OPENING THE PACKAGING AND COULD NOT BE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13158013 ↗MalfunctionSep 25, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated
THE COMPLAINANT REPORTED THAT THE WIRE GUIDE BECAME LODGED DURING A THORACENTESIS PROCEDURE, AND IT UNRAVELED INSIDE OF THE PATIENT IN THE SHEATH DURING REMOVAL. IT WAS FURTHER NOTED THAT THE SAFETY WIRE SEPARATED FROM THE DISTAL WELD CONNECTION. 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 7906696 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.