BanderRecalls & reported problems across all models
Cook Incorporated · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 11 models of Bander by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between May 17, 2016 and Jul 8, 2026 — classified as 8 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bander problems
Device problems
- Device Contamination with Chemical or Other Material6
- Break5
- Migration or Expulsion of Device3
- Unraveled Material2
- Complete Blockage1
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Use1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- No Patient Involvement5
- No Clinical Signs, Symptoms or Conditions4
- No Code Available3
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Perforation1
Bander models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bander G14779CATHETER, NEPHROSTOMY3 reports
- Bander G14822CATHETER, NEPHROSTOMY3 reports
- Bander G16817CATHETER, NEPHROSTOMY3 reports
- Bander G16994CATHETER, NEPHROSTOMY3 reports
- Bander G18070CATHETER, NEPHROSTOMY3 reports
- Bander G16818CATHETER, NEPHROSTOMY2 reports
- Bander G16996CATHETER, NEPHROSTOMY2 reports
- Bander G14823CATHETER, NEPHROSTOMY1 report
- Bander G16995CATHETER, NEPHROSTOMY1 report
- Bander G16997CATHETER, NEPHROSTOMY1 report
- Bander G17186CATHETER, NEPHROSTOMY1 report
Recent Bander adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 17130828 ↗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 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 ↗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 ↗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 ↗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 ↗MalfunctionApr 11, 2018Break; Unraveled Material
THE COMPLAINANT REPORTED THAT THE WIRE STRIPPED AND BROKE PRIOR TO PATIENT CONTACT. THE DEVICE WAS UNRAVELING WHEN IT WAS REMOVED FROM THE PACKAGE OF THE BANDER URETERAL DIVERSION STENT SET AND A NEW WIRE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR END USER AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7421222 ↗MalfunctionApr 11, 2018Entrapment of Device
THE COMPLAINANT REPORTED THAT THE BANDER URETERAL DIVERSION STENT HAD BEEN PLACED FOR ILEUM CONDUIT FOR ABOUT 3 WEEKS. ANASTOMOTIC STENOSIS WAS OBSERVED. THE USER INSERTED THE SUPPLIED WIRE GUIDE INTO THE STENT TO EXCHANGE FOR NEW ONE, BUT THE WIRE GUIDE GOT STUCK IN THE STENT. IT WAS FURTHER NOTED THAT THE COILS ON THE SAFETY WIRE WERE STRETCHED. THE USER THEN INSERTED ANOTHER MANUFACTURER'S WIRE GUIDE ALONG THE STENT AND REMOVED THE STENT AND THE WIRE GUIDE TOGETHER FROM THE PATIENT. THE NEW BANDER URETERAL DIVERSION STENT WAS INSERTED OVER THE OTHER MANUFACTURER'S WIRE GUIDE AND PLACED SUCCESSFULLY. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7421125 ↗MalfunctionApr 10, 2018Obstruction of Flow; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN STENT EXCHANGE FOR URETEROCUTANEOUS FISTULA WAS PERFORMED, THERE WAS AN OBSTRUCTION IN THE STENT LUMEN. IT WAS FURTHER NOTED THAT A FOREIGN SUBSTANCE WAS OBSERVED INSIDE THE CATHETER. THE USER REPLACED IT WITH ANOTHER BANDER URETERAL DIVERSION STENT AND COMPLETED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7411525 ↗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 ↗MalfunctionApr 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE DISTRIBUTER FOUND THAT THERE WAS A BLACK FOREIGN MATTER IN THE PACKAGE. 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 7406754 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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