Cook G00902Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002009028), received between Jun 25, 2018 and Sep 1, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.
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
- Adverse Event Without Identified Device or Use Problem1
- Material Protrusion/Extrusion1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Sepsis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2022Unraveled Material; Unraveled Material
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE UNRAVELED IN THE PATIENT. THE ENTIRE WIRE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335619 ↗MalfunctionMay 31, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, THE PHYSICIAN NOTICED THAT A PORTION OF THE BRAIDED WIRE WAS STICKING OUT OF A SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8658847 ↗InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, A FEMALE PATIENT IN HER "(B)(6)" WITH A NON-HEALING, LEFT FOOT, VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470); KCFW-5.0-38-RB (1820334-2018-01613); KCFW-6.0-18/38-45-RB-ANL0-HC (1820334-2018-01614); MPIS-402-NT-U-SST (1820334-2018-01615); PTA5-35-135-6-6.0 (1820334-
Patient problems: Sepsis
MAUDE report 7634314 ↗
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.
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