Koyle G17668Recalls & reported problems
Cook Incorporated · Koyle Diaper Stent Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002176683), received between Apr 6, 2017 and Sep 29, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected2
- Break1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2017Device Operates Differently Than Expected; Material Twisted/Bent; Device Operates Differently Than Expected; Material Twisted/Bent
THE USER FACILITY REPORTED THE KOYLE DIAPER URETHRAL STENT IS TWIRL WHEN REMOVING THE MANDRIN. FURTHER CLARIFICATION WAS PROVIDED AND EXPLAINED THAT THE STENT WAS CURLING AFTER TAKING OUT THE INNER STYLET. THE STENT WAS NOT IN CONTACT WITH THE PATIENT OR IN THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6904141 ↗MalfunctionApr 6, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A STENT PLACEMENT URETHRAL PROCEDURE. THE DEVICE IN USE WAS A KOYLE DIAPER URETHRAL STENT. IT WAS REPORTED THAT THE STENT INSIDE THE TUBE IS SNAPPING WHEN THE DOCTOR IS TRYING TO MOVE IT. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6464655 ↗
Other CATHETER, UROLOGICAL devices
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- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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