Bander G16818Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002168183), received between May 9, 2018 and Jul 3, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
WHEN THE DEVICE ARRIVED AT THE HOSPITAL, IT WAS NOTED THAT THERE WAS AN UNIDENTIFIED FOREIGN MATTER SEALED INSIDE THE STERILE POUCH. THEREFORE, IT WAS REPLACED WITH ANOTHER 025706-S1. THIS PRODUCT WAS NOT USED ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7659397 ↗MalfunctionMay 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A HAIR-LIKE SUBSTANCE WHICH WAS INSIDE THE STERILISED PACKAGING OF THE BANDER URETERAL DIVERSION STENT SET. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7500437 ↗
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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