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Cook G17843Recalls & reported problems

Cook Incorporated · Urethral Dilation Balloon 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 00827002178434), received between Feb 8, 2018 and Feb 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

  • Component Missing1

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.

  • MalfunctionFeb 8, 2018Component Missing; Component Missing

    IT WAS REPORTED UPON OPENING THE PACKAGING OF THE URETHRAL DILATION BALLOON CATHETER, THE BALLOON WAS NOT EQUIPPED WITH THE FILIFORM TIP. THE FILIFORM TIP WAS NOT IN THE PACKAGING. THE URETHRA DILATATION PROCEDURE TO TREAT URETHRA STRICTURES IN A MALE PATIENT WAS UNABLE TO PROCEED FURTHER BECAUSE OF THE MISSING FILIFORM TIP. AS REPORTED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7251838 ↗

Other DILATOR, URETHRAL devices

All DILATOR, URETHRAL devices →

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