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Cook G15429Recalls & reported problems

Cook Incorporated · Urodynamics Catheter · 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 00827002154292), received between Aug 7, 2018 and Aug 7, 2018 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionAug 7, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED, PRIOR TO OPENING THE STERILE PACKAGE OF THE URODYNAMICS CATHETER, A "HAIR LIKE" MATERIAL WAS OBSERVED INSIDE THE PACKAGE. NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7758010 ↗

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.