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Cook G14320Recalls & reported problems

Cook Incorporated · Balloon Ureteral Dilator Set · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002143203), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

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.

  • MalfunctionApr 10, 2018Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE URETERAL BALLOON COULD NOT LOAD ONTO THE WIRE. IT WAS FURTHER NOTED THAT YELLOW MATERIAL WAS VISIBLE IN THE INNER DIAMETER, BLOCKING THE LUMEN. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7411985 ↗

Other DILATOR, CATHETER, URETERAL devices

All DILATOR, CATHETER, URETERAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.