Polaris™ Ultra M006193132090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729762911), received between Nov 10, 2017 and Dec 6, 2023 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED TO TREAT URINARY LITHIASIS USING A TRANS URETERAL LITHOTRIPSY PROCEDURE IN THE URINARY TRACT. THE EVENT DATE WAS UNKNOWN. DURING THE PROCEDURE, THE STENT WAS FOUND DAMAGED. IT WAS NOTED THAT THE PIGTAIL FLAP WAS SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279274 ↗
• MalfunctionAug 27, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS OPEN TO BE USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, PRIOR TO PROCEDURE, WHEN THEY OPENED THE PACKAGE, IT WAS NOTICED THAT THE INSIDE BOX OF THE STENT WAS FOUND TO BE OPENED, THE SEAL WAS PEELED OFF. ANOTHER POLARIS ULTRA URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10458943 ↗
• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS UNPACKED FOR USE FOR A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE PIGTAIL WAS TORN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT SHAFT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461864 ↗
• MalfunctionNov 10, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ LOOP URETERAL STENT WAS USED IN THE URETER DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT STENT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX¿ LOOP URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7019848 ↗