Jeffery G04432Recalls & reported problems
Cook Incorporated · Jeffery Wire Guide Exchange Set With Cope Platinum-Tipped Stainless Steel Wire Guide · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002044326), received between Jul 20, 2017 and Feb 27, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Contamination /Decontamination Problem1
Patient problems
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.
Patient problems: No Patient Involvement
MAUDE report 8375310 ↗InjuryJul 20, 2017Break; Break
CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A URETEROSCOPY USING A JEFFREY WIRE GUIDE EXCHANGE SET. THE REPORT INDICATES THAT THE "WIRE BROKE OFF IN PATIENTS BODY AND WAS REMOVED IMMEDIATELY." THE CIRCUMSTANCES AND HANDLING CONDITIONS AT THE TIME OF THE EVENT ARE NOT KNOWN. THE ANATOMICAL SITE OF THE BROKEN WIRE WAS NOT PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. THE CUSTOMER LATER REPORTED DURING A RESPONSE TO ADDITIONAL INFORMATION THAT THE DEVICE DID NOT FRACTURE, BUT RATHER UNRAVELED ABOUT A CENTIMETER FROM THE TIP. THE UNRAVELING OF THE WIRE OCCURRED WHEN THE OPERATOR ATTEMPTED TO DRAW BACK ON THE WIRE AND REMOVE IT ALONGSIDE THE SHEATH. EVENTUALLY, ONCE THE ACCESS SHEATH WAS REMOVED, THE WIRE WAS REMOVED COMPLETELY AS WELL. THE CUSTOMER CONFIRMED THAT THE WIRE WAS DISCARDED BY THE OPERATING ROOM STAFF, AND AS SUCH THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.
Patient problems: No Code Available
MAUDE report 6730261 ↗
Other ACCESSORIES, CATHETER devices
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- Extension Set 456025B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Centeze Centesis Catheter DRC-002-05Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Centeze Centesis Catheter DRC-002-06Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Neff G10544Cook Incorporated · ACCESSORIES, CATHETER45 reports
- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 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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