Bander G16997Recalls & reported problems
Cook Incorporated · Bander Ureteral Diversion Stent Set · Class U · Implant
All models of Bander (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002169975), received between Jul 8, 2026 and Jul 8, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Break
IT WAS REPORTED THAT, DURING THE PROCEDURE OF URETERAL STENT REMOVAL, A BANDER URETERAL DIVERSION STENT SET FRACTURED WHILE BEING REMOVED. THE PATIENT HAD A PREVIOUSLY PLACED URETERAL STENT, LEAVING A RETAINED FRAGMENT STENT WITHIN THE URINARY TRACT. THE RETAINED FRAGMENT COULD NOT BE RETRIEVED USING STANDARD CYSTOSCOPIC TECHNIQUES. AS A RESULT OF THIS DEVICE FAILURE, THE PATIENT WILL REQUIRE AN ADDITIONAL OPERATIVE INTERVENTION. A PERCUTANEOUS NEPHROLITHOTOMY (PCNL)-TYPE PROCEDURE WITH PERCUTANEOUS RENAL ACCESS WILL BE NECESSARY TO RETRIEVE THE RETAINED STENT FRAGMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 25752053 ↗
Other CATHETER, NEPHROSTOMY devices
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- 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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