Cook G02008Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Safe-T-J, Curved · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002020085), received between Aug 8, 2018 and Mar 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Unraveled Material2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT "THE SHEATH ON THE OUTSIDE OF THE WIRE" IS THE GREEN COILING OF THE WIRE GUIDE. THE J-TIP OF THE WIRE WAS NOT MANIPULATED/ALTERED PRIOR TO USE. IT WAS STRAIGHTENED OUT IN THE USUAL WAY TO ALLOW INSERTION OF THE WIRE INTO THE EXISTING DRAINAGE CATHETER (ULT8.5-38-25-P-6S-CLM-RH) TO STRAIGHTEN OUT THE PIGTAIL FOR THE CATHETER EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961937 ↗MalfunctionMar 22, 2024Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959656 ↗MalfunctionAug 8, 2018Material Deformation; Material Deformation
AN INTERNATIONAL CUSTOMER REPORTED THAT A SAFE-T-J NEPHROSTOMY DRAINAGE SET FIXED CORE WIRE GUIDE WAS USED TO EXCHANGE A NEPHROSTOMY TUBE. THE WIRE GUIDE HAD DIFFICULTY ADVANCING THROUGH THE TUBE AND STRAIGHTENING AT THE END. A RADIOLOGIST ASSISTED IN FEEDING THE GUIDE WIRE THROUGH THE TUBE AND OBSERVED THE GUIDE WIRE TO BE "FLOPPY" AND THE OUTER/COVERING SHEATH HAD COME AWAY WHEN EXCHANGING THE OLD TUBE OVER THE GUIDE WIRE. A NEW NEPHROSTOMY TUBE WAS EXCHANGED OVER THE GUIDE WIRE AND THE GUIDE WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED AS INTENDED. DEVICE EVALUATION IDENTIFIED ELONGATION OF THE GUIDE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7764696 ↗
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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