Cook G07304Recalls & reported problems
Cook Incorporated · Australian Mandril Wire Guide Stainless Steel · 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002073043), received between Apr 23, 2018 and Mar 6, 2023 — classified as 2 injuries, 3 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.
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-1843-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Unraveled Material2
- Fracture1
- Material Frayed1
- Material Separation1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 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 16491831 ↗MalfunctionFeb 4, 2022Unraveled Material
ATTENDING WAS PLACING A CVL IN A PATIENT WHO WAS REQUIRING VASOPRESSORS. 18G WIRE UNCOILED INSIDE OF THE PATIENT. THE ATTENDING WAS ABLE TO REMOVE THE GUIDEWIRE WITHOUT HARM TO THE PATIENT. MULTIPLE WIRES WERE USED AND THE LINE WAS UNSUCCESSFUL.
Patient problems: Failure of Implant
MAUDE report 13450825 ↗MalfunctionMar 12, 2021Material Frayed
CENTRAL LINE PLACEMENT - UPON REMOVING GUIDEWIRE RESIDENT REALIZED GUIDEWIRE WAS FRAYED INDICATING WIRE WAS NOT FULLY INTACT. CONCERN FOR POSSIBILITY THAT FRAYED PIECE OF THE GUIDEWIRE WAS INSIDE PATIENT. RETAINED FOREIGN OBJECT IDENTIFIED ON CT SCAN.
Patient problems: Foreign Body In Patient
MAUDE report 11472788 ↗InjuryMar 3, 2021Material Separation; Material Separation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE LAST MEDWATCH REPORT WAS SUBMITTED.
Patient problems: Foreign Body In Patient
MAUDE report 11406639 ↗InjuryApr 23, 2018Fracture; Fracture
THE CUSTOMER REPORTED THAT A PIECE OF MICRO WIRE FROM A TORQ-FLEX (B)(6) MODIFICATION MANDRIL WIRE GUIDE WAS LEFT IN THE RIGHT FEMORAL AREA SUBCUTANEOUSLY WHILE THE DEVICE OPERATOR WAS TRYING TO GET ACCESS FEMORALLY TO PATIENT. IT IS CURRENTLY UNKNOWN IF A RETRIEVAL OF THE FRAGMENT WAS ATTEMPTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7450099 ↗
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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