Bander G16994Recalls & reported problems
Cook Incorporated · Bander Ureteral Diversion Stent Set Wire Guide With Hydrophilic Coating · 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 00827002169944), received between Apr 13, 2018 and Feb 9, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Difficult to Advance1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2022Break; Break
PER USER FACILITY REPORT # MW5105955, DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO BANDER URETERAL DIVERSION STENTS WERE PLACED BILATERALLY. THE STENTS WERE REMOVED ON POST-OPERATION DAY 11. UPON REMOVAL, ONE OF THE STENTS BROKE. THE BROKEN PIECE OF THE STENT WAS ABLE TO BE REMOVED BY MANUAL MANIPULATION THROUGH THE OSTOMY. NO PATIENT HARM WAS REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13497385 ↗InjurySep 12, 2019Difficult to Advance; Difficult to Advance
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 12SEP2019.
Patient problems: Perforation
MAUDE report 9013893 ↗MalfunctionApr 13, 2018Unraveled Material
THE COMPLAINANT REPORTED THAT THE GUIDE WIRE FROM THE BANDER URETERAL DIVERSION STENT SET UNRAVELED WHEN IT WAS REMOVED FROM THE DELIVERY SYSTEM. THE PRODUCT DID NOT MAKE PATIENT CONTACT, AND THIS PRODUCT PROBLEM OCCURRED DURING UNPACKAGING/PREPARATION. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7428553 ↗
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.
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