Bander G14823Recalls & reported problems
Cook Incorporated · Bander Ureteral Diversion Open-End 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 00827002148239), received between Apr 11, 2018 and Apr 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2018Entrapment of Device
THE COMPLAINANT REPORTED THAT THE BANDER URETERAL DIVERSION STENT HAD BEEN PLACED FOR ILEUM CONDUIT FOR ABOUT 3 WEEKS. ANASTOMOTIC STENOSIS WAS OBSERVED. THE USER INSERTED THE SUPPLIED WIRE GUIDE INTO THE STENT TO EXCHANGE FOR NEW ONE, BUT THE WIRE GUIDE GOT STUCK IN THE STENT. IT WAS FURTHER NOTED THAT THE COILS ON THE SAFETY WIRE WERE STRETCHED. THE USER THEN INSERTED ANOTHER MANUFACTURER'S WIRE GUIDE ALONG THE STENT AND REMOVED THE STENT AND THE WIRE GUIDE TOGETHER FROM THE PATIENT. THE NEW BANDER URETERAL DIVERSION STENT WAS INSERTED OVER THE OTHER MANUFACTURER'S WIRE GUIDE AND PLACED SUCCESSFULLY. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7421125 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.