Bander G14822Recalls & reported problems
Cook Incorporated · Bander Ureteral Diversion Open-End Stent Set · Class U · Implant
All models of Bander (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002148222), received between Oct 24, 2016 and Apr 10, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device2
- Device Contamination with Chemical or Other Material1
- Failure to Advance1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2018Failure to Advance; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE PROCEDURE, THE URETERAL DIVERSION STENT DID NOT ADVANCE OVER A WIRE GUIDE. IT WAS FURTHER NOTED THAT A MILKY, STICKY FOREIGN MATTER WAS OBSERVED INSIDE THE CATHETER. ANOTHER DEVICE WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7411276 ↗MalfunctionOct 24, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT AFTER SEVERAL URETEROCUTANEOSTOMY PROCEDURES PATIENTS' PROSTHESES BECAME DISPLACED. IT WAS UNKNOWN WHETHER OR NOT THE PROSTHESES WERE TOO SOFT TO REMAIN IN PLACE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6050461 ↗InjuryOct 24, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT AFTER SEVERAL URETEROCUTANEOSTOMY PROCEDURES, PATIENTS' PROSTHESES BECAME DISPLACED. IT WAS UNKNOWN WHETHER OR NOT THE PROSTHESES WERE TOO SOFT TO REMAIN IN PLACE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6050446 ↗
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
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 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.
How reports and recalls are matched · Editorial policy · Report an error on this page