Bander G14779Recalls & 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
- 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 00827002147799), received between Sep 13, 2019 and May 26, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Break
IT WAS REPORTED THAT DURING USE OF THE BANDER URETERAL DIVERSION STENT SET, THE STENT WAS OBSERVED TO HAVE BROKEN. THE DEVICE FRACTURED WITH ONLY SLIGHT TRACTION. NO PORTION OF THE STENT REMAINED INSIDE THE PATIENT. THE USER REPLACED IT WITH A NEW BANDER URETERAL DIVERSION STENT SET AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277837 ↗MalfunctionJun 18, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282633 ↗InjurySep 13, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED DURING AN ATTEMPT TO REMOVE BANDER URETERAL DIVERSION STENT SET AFTER INDWELLING APPROXIMATELY 61 DAYS, THE USER HAD DIFFICULTY REMOVING THE STENT FROM THE PATIENT. IT WAS FOUND THAT THE STENT HAD TIED IN A KNOT. 2 DAYS LATER, THE PATIENT DEVELOPED A FEVER AND WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH ANTI-INFECTIVES. THIS REPORTEDLY ¿DID NOT TURN OUT WELL¿ (CLARIFICATION HAS BEEN REQUESTED). THE NEXT DAY, A RENAL NEPHROSTOMY WAS PERFORMED TO ALLOW URINE DRAINAGE. ONE WEEK LATER, THE STENT WAS REMOVED (NO DETAILS PROVIDED ON HOW THE STENT WAS EVENTUALLY REMOVED). (B)(6) 2019 IT WAS REPORTED THAT THE PATIENT IS NOW WELL WITH NO FEVER OR STOMACHACHE. EXACT DATE OF SYMPTOM RESOLUTION IS UNKNOWN. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 9031063 ↗
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- 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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