Cook G14430Recalls & reported problems
Cook Incorporated · Open-End Ureteral Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002144309), received between Apr 9, 2018 and Nov 30, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
- Device Contaminated During Manufacture or Shipping1
- Occlusion Within Device1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionNov 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 15891276 ↗MalfunctionApr 9, 2018Partial Blockage; Occlusion Within Device
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THERE WAS A BLOCKAGE WHEN THE THREAD WAS PASSED THROUGH THE OPEN-END URETERAL CATHETER. IT WAS FURTHER NOTED THAT THE DISTAL CATHETER WAS OCCLUDED WITH A SMALL AMOUNT OF GREEN PLASTIC. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7409564 ↗
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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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