Koyle G17667Recalls & reported problems
Cook Incorporated · Koyle Diaper Stent · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002176676), received between Nov 28, 2018 and Nov 28, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage2
- Material Deformation1
- No Flow1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2018No Flow
IT WAS REPORTED THAT THE KOYLE DIAPER URETHRAL STENT WAS NOT ALLOWING URINE TO FLOW, ALTHOUGH IT WAS NOT KINKED. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REPLACE THE STENT, BUT THERE WERE NO INJURIES ASIDE FROM THIS PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8113416 ↗MalfunctionNov 28, 2018Obstruction of Flow
IT WAS REPORTED THAT THE KOYLE DIAPER URETHRAL STENT WAS OBSTRUCTED FROM THE INSIDE. THIS WAS FOUND PRIOR TO PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8112653 ↗MalfunctionNov 28, 2018Complete Blockage; Material Deformation
IT WAS REPORTED THAT THE DIAPER URETHRAL STENT WAS BLOCKED FROM INSIDE. IT WAS FURTHER NOTED THAT THE TUBING UNDER THE CUFF APPEARED TO BE SMASHED. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8111836 ↗MalfunctionNov 28, 2018Complete Blockage
IT WAS REPORTED THAT THE KOYLE DIAPER URETHRAL STENT WAS USED FOR A HYPOSPADIAS PROCEDURE, BUT IT WAS BLOCKED AND COULD NOT BE FLUSHED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8111444 ↗
Other CATHETER, URETHRAL devices
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- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.