Cook G04648Recalls & reported problems
Cook Incorporated · Double Flexible Tipped Wire Guide · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002046481), received between Nov 21, 2017 and Jan 13, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3 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.
Most reported problems
Device problems
- Material Separation3
- Solder Joint Fracture3
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2021Material Separation; Solder Joint Fracture; Material Separation; Solder Joint Fracture
IT WAS NOTED DURING THE PHYSICAL EXAMINATION ON (B)(6) 2021 OF THE DEVICE THAT THE SOLDER/WELD TIP BROKE, AND THAT THERE WAS NO SEPARATION AS PREVIOUSLY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11162465 ↗MalfunctionJan 12, 2021Material Separation; Solder Joint Fracture; Material Separation; Solder Joint Fracture
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE FOR AN ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, THE WIRE SNAPPED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11158131 ↗MalfunctionJan 12, 2021Material Separation; Solder Joint Fracture; Material Separation; Solder Joint Fracture
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 11158098 ↗MalfunctionNov 21, 2017Unraveled Material; Unraveled Material
IT WAS REPORTED THAT DURING A PROCEDURE, WITHDRAWAL OF THE STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE WAS DIFFICULT, AND ELONGATED CREATING A SPRING-LIKE EFFECT. FOLLOWING SUCCESSFUL COMPLETION OF THE PROCEDURE, A STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE WITH THE SAME LOT NUMBER WAS TESTED AND PRESENTED THE SAME MALFUNCTION. ACCORDING TO THE INITIAL REPORTER, NO PORTION OF THE DEVICE SEPARATED AND/OR REMAINED IN THE PATIENT, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7050268 ↗
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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