Cook G00617Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Straight · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002006171), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (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-1834-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Packaging Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2018Packaging Problem; Packaging Problem
IT WAS REPORTED THAT PRIOR TO USE, THREE STRAIGHT FIXED CORE WIRE GUIDES WERE OBSERVED TO BE INCORRECTLY PACKAGED. PER THE REPORTER, NORMALLY THE SOFT TIP OF THE WIRE REACHES OUT OF THE PLASTIC HOLDER WHEN THE PRODUCT IS OPENED; HOWEVER, THE STIFF END OF THE WIRE WAS AT THE OPEN END OF THE HOLDER. THE DEVICES DID NOT COME INTO CONTACT WITH A PATIENT. IT WAS NOTED THAT THE DEVICES COULD BE UTILIZED; HOWEVER, INCORRECT PACKAGING PRESENTED THE POTENTIAL FOR THE WIRE GUIDES TO BE MISUSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7348465 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.