Cook G00529Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002005297), received between Jul 5, 2017 and Jul 10, 2025 — classified as 1 injury, 16 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Unraveled Material12
- Difficult to Remove5
- Material Protrusion/Extrusion3
- Break2
- Material Twisted/Bent2
- Material Deformation1
- Material Frayed1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient6
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Pain
MAUDE report 22472935 ↗MalfunctionJun 23, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION RECEIVED ON 29JUN2025, IT WAS CONFIRMED THAT THE WIRE WAS NOT MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE. THE PHYSICIAN PULLED THE DAMAGED WIRE OUT OF THE DRAINAGE CATHETER WITH FORCE AT THE COMPLETION OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309882 ↗MalfunctionOct 4, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 20373623 ↗MalfunctionAug 28, 2024Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
IT WAS REPORTED THAT A SAFE-T-J FIXED CORE WIRE GUIDE UNRAVELED. PRIOR TO PATIENT CONTACT, THE PURPLE WIRE GUIDE STRAIGHTENER WAS USED TO AID WIRE ADVANCEMENT INTO THE NEEDLE; HOWEVER, WHEN THE STRAIGHTENER WAS MOVED, THE COIL UNRAVELED, AND THE MANDREL POKED UP. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20092107 ↗MalfunctionJun 26, 2023Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2023. IT WAS REPORTED THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. THE WIRE GUIDE WAS NOT WITHDRAWN NOR MANIPULATED THROUGH THE NEEDLE. THE WIRE GUIDE DID NOT SEPARATE BUT WAS A "LITTLE UNCOUPLED" AND ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17203972 ↗MalfunctionMar 9, 2023Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16517689 ↗MalfunctionSep 15, 2022Break; Unraveled Material; Break; Unraveled Material
IT WAS REPORTED THE SAFE-T-J FIXED CORE WIRE GUIDE MALFUNCTIONED. WHILE USING THE WIRE GUIDE TO PLACE THE DRAIN, THE WIRE SEPARATED IN THE PATIENT. AT THIS TIME, NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15429054 ↗MalfunctionMay 25, 2022Difficult to Remove; Unraveled Material; Material Twisted/Bent; Difficult to Remove; Unraveled Material; Material Twisted/Bent
IT WAS REPORTED A SAFE-T-J FIXED CORE WIRE GUIDE WAS DAMAGED DURING A DRAIN INSERTION PROCEDURE. WHEN REMOVING THE METAL STYLET OF THE CATHETER, THE WIRE WAS REPORTEDLY "SEVERELY KINKED, STRETCHED, AND UNABLE TO BE REMOVED FROM THE INSIDE OF THE STYLET." THIS MADE THE DEVICE UNUSABLE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14498480 ↗MalfunctionMay 25, 2022Difficult to Remove; Unraveled Material; Material Twisted/Bent; Difficult to Remove; Unraveled Material; Material Twisted/Bent
IT WAS REPORTED A SAFE-T-J FIXED CORE WIRE GUIDE WAS DAMAGED DURING A DRAIN INSERTION PROCEDURE. WHEN REMOVING THE METAL STYLET OF THE CATHETER, THE WIRE WAS REPORTEDLY "SEVERELY KINKED, STRETCHED, AND UNABLE TO BE REMOVED FROM THE INSIDE OF THE STYLET." THIS MADE THE DEVICE UNUSABLE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14498264 ↗MalfunctionAug 6, 2021Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION PROVIDED ON 17AUG2021, IT WAS REPORTED THAT THE WIRE GUIDE WAS NOT WITHDRAWN THROUGH A NEEDLE AT ANY POINT DURING THE PROCEDURE. THE PATIENT WAS REPORTED TO NOT HAVE TORTUOUS ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12290686 ↗MalfunctionFeb 22, 2021Stretched; Stretched
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 11362024 ↗MalfunctionOct 26, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10734987 ↗MalfunctionMar 20, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT AN UNKNOWN PATIENT REQUIRED THE USE OF A SAFE-T-J FIXED CORE WIRE GUIDE FOR AN UNKNOWN PROCEDURE. UPON OPENING THE PACKAGE, THE OPERATOR NOTED THE DEVICE WAS BENT. THIS OCCURRED PRIOR TO PATIENT CONTACT. THE DEVICE WAS RETURNED FOR INVESTIGATION AND UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS NOTICED THE MANDRIL WIRE WAS PROTRUDING BETWEEN THE COILS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9859846 ↗MalfunctionJan 15, 2020Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9592812 ↗MalfunctionJul 26, 2019Material Frayed; Material Deformation; Material Frayed; Material Deformation
MalfunctionMar 25, 2019Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn
PREVIOUSLY REPORTED: IN RESPONSE TO ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2019, THE CUSTOMER REPORTED THAT DURING REMOVAL OF THE COMPLAINT DEVICE, NO RESISTANCE WAS ENCOUNTERED BY THE USER AS "THE WIRE WAS BEING REMOVED THROUGH THE TROCAR INCLUDED IN THE PIGTAIL CATHETER KIT." NO KINKING OF THE WIRE WAS NOTED DURING THE PROCEDURE. CORRECTION: IN RESPONSE TO ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THAT DURING REMOVAL OF THE COMPLAINT DEVICE, RESISTANCE WAS ENCOUNTERED BY THE USER AS "THE WIRE WAS BEING REMOVED THROUGH THE TROCAR INCLUDED IN THE PIGTAIL CATHETER KIT." NO KINKING OF THE WIRE WAS NOTED DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE COMPLAINT DEVICE WAS PLACED IN THE "LEFT LOWER QUADRANT (FOR) INTRA-ABDOMINAL FLUID COLLECTION", WHICH WAS ACCOMPLISHED "THROUGH AN 18G INTRODUCER NEEDLE." THE ISSUE WAS NOTED DURING THE PROCEDURE AND THE PATIENT REQUIRED "AN ABDOMINAL X-RAY TO ASSESS FOR WIRE FRAGMENTS." THE PATIENT WAS "BED BOUND" AND "THE CATHETER WAS LOCKED AT THE END OF THE PROCEDURE WHEN IT WAS ATTACHED UP TO THE DRAINAGE BAG."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8449468 ↗InjuryJul 5, 2017Break; Break
CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A DRAINAGE PROCEDURE USING A SAFE-T-J FIXED CORE WIRE GUIDE. THE GUIDE WIRE BROKE WITHIN THE ABDOMINAL WALL DURING PLACEMENT. A PHYSICIAN CONSULT DETERMINED THAT THERE IS NO NEED FOR SURGICAL INTERVENTION DUE TO THE SIZE AND LOCATION OF THE FRAGMENT; THE FRAGMENT REMAINS RETAINED WITHIN THE ABDOMINAL WALL. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE. A PORTION OF THE BROKEN DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6686547 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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 · each recall links to the FDA recall notice
- 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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