Bander G18070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002180703), received between May 17, 2016 and Dec 19, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE URETERAL STENT PRODUCT IS TOO SOFT AND SLIPS OFF TOO EASILY. THE REPORTER STATED, ¿THE LIFE OF THIS DEVICE IS SIX MONTHS BUT IN REALITY IT MUST BE REPLACED IN THE PATIENT WITHIN THREE MONTHS, THE PATIENT ALSO FINDS IT DIFFICULT TO LEAVE IN PLACE." AS STATED IN THE COMPLAINT FORM FROM THE REPORTER "PRODUCT IS TOO SOFT, YOU CAN NOT CHANGE IT AFTER 6 MONTHS (AS STATED IN THE DATA SHEET) FOR THESE REASONS IT IS NECESSARY TO REPEAT THE STENT REPLACEMENT PROCEDURE.¿ ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6185070 ↗
• InjuryDec 16, 2016Complete Blockage; Complete Blockage

  IT WAS REPORTED THE URETERAL STENT PRODUCT ¿CLOGS IMMEDIATELY.¿ THE REPORTER STATED ¿STENT SHOULD BE REPLACED LATEST AFTER FOUR MONTHS BECAUSE CLOG IMMEDIATELY.¿ THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6181701 ↗
• InjuryMay 17, 2016Occlusion Within Device; Occlusion Within Device

  THE FEMALE PATIENT HAD THE URETERAL STENT PLACED ON (B)(6) 2016. THE PROCEDURE WENT WELL. AFTER TWO DAYS THEY REALIZED THAT THE STENT HAD BEEN ENGORGED BY LITHO-PROBLEMS. THE USER FACILITY REMOVED THE STENT AND HAD TO RE-OPERATE ON THE PATIENT. WHEN THE DOCTOR RE-OPENED THE PATIENT, HE DECIDED TO USE ANOTHER MANUFACTURER'S CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Code Available

  MAUDE report 5660892 ↗