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Cook G14185Recalls & reported problems

Cook Incorporated · Urethral Dilator Set · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002141858), received between May 15, 2018 and Apr 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

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 Material2
  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 14, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    AS REPORTED, A HAIR WAS FOUND INSIDE AN UNOPENED URETHRAL DILATOR SET'S STERILE PACKAGE. THE DEVICE WAS NOT USED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14113631 ↗
  • MalfunctionAug 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    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 12337200 ↗
  • MalfunctionMay 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT A HAIR CAN BE SEEN IN THE POUCH WHICH THE URETHRAL DILATOR SET WAS PACKAGED IN. THEREFORE, THE USER DIDN'T USE THE URETHRAL DILATOR SET AS THE STERILIZATION MAY HAVE BEEN COMPROMISED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Patient problems: No Patient Involvement

    MAUDE report 7515876 ↗

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.