Dretler G15735Recalls & 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 00827002157354), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
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.
MalfunctionNov 1, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED, UPON OPENING THE DRETLER URETEROSCOPY STENT SET PACKAGE, THE PHYSICIAN NOTICED THAT AN UNIDENTIFIED FOREIGN MATTER WAS ATTACHING ON THE TIP OF THE CATHETER. THE PHYSICIAN PICKED THE FOREIGN MATTER AND PULLED IT BACK TO REMOVE IT FROM THE CATHETER, A 10CM STRING CAME OUT OF THE INNER LUMEN THEN. THE FOREIGN MATTER WAS REVEALED TO BE A STRING, THOUGH FROM WHERE IT ORIGINATED WAS UNKNOWN. IT WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030234 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.