Cook G14030Recalls & reported problems
Cook Incorporated · Whistle Tip Ureteral Catheter (Right) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00827002140301), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2019Material Separation; Material Separation
IT IS REPORTED A PATIENT HAD A RADICAL HYSTERECTOMY WITH BILATERAL OOPHORECTOMY AND PLACEMENT OF BILATERAL COOK WHISTLE TIP URETERAL CATHETERS. TWO DAYS LATER, URINE LEAKAGE WAS OBSERVED. THREE DAYS AFTER URINE LEAKAGE WAS NOTED, IT WAS ARRANGED FOR THE COOK WHISTLE TIP URETERAL CATHETERS TO BE REMOVED BY A UROLOGIST. AT THIS TIME IT WAS FOUND THAT ONE OF THE CATHETERS WAS BROKEN AND A PART WAS LEFT INSIDE THE PATIENT'S BODY. AN UNSPECIFIED TIME PERIOD LATER, SURGERY WAS ARRANGED TO REMOVE THE RETAINED SECTION OF THE CATHETER. THE PATIENT'S OUTCOME WAS GOOD. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL DETAILS REGARDING THE PATIENT AND THE EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Code Available
MAUDE report 8613447 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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