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Dretler G17813Recalls & reported problems

Cook Incorporated · Dretler Ureteroscopy Stent Set · Class U · Implant

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 00827002178137), received between Feb 22, 2022 and Feb 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 22, 2022Detachment of Device or Device Component; Device Contaminated During Manufacture or Shipping; Detachment of Device or Device Component; Device Contaminated During Manufacture or Shipping

    AS REPORTED, PRIOR TO THE DISTRIBUTOR DELIVERING A DRETLER UNIVERSAL URETEROSCOPY STENT SET TO THE HOSPITAL, THEY NOTICED A BLACK FOREIGN SUBSTANCE. THE FOREIGN SUBSTANCE APPEARS TO BE A RING. THE DEVICE WAS NOT SENT TO THE HOSPITAL, BUT THEY PLAN TO DELIVER ANOTHER SAME TYPE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13577774 ↗

Other CATHETER, NEPHROSTOMY devices

All CATHETER, NEPHROSTOMY devices →

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