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Cook G16987Recalls & reported problems

Cook Incorporated · Urodynamic Balloon Catheter Triple Lumen With Coude' Tip and Modified Sideports · 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 00827002169876), received between Nov 29, 2018 and Nov 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

  • Burst Container or Vessel1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 29, 2018Burst Container or Vessel

    IT WAS REPORTED THAT DURING THE USE OF URODYNAMICS BALLOON CATHETER FOR CYSTOMETRY STUDIES, THE BALLOON "EXPLODED". IT WAS FURTHER NOTED THAT THE BALLOON MATERIAL WAS SPLIT FROM PROXIMAL BOND TO DISTAL BOND. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. A NEW PRODUCT WAS USED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8116653 ↗

Other CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE devices

All CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE devices →

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