Polaris™ Loop M006155232090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729765516), received between Mar 16, 2017 and Sep 10, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

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

• MalfunctionSep 10, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPENED TO BE USED DURING A STENT REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, OUTSIDE OF THE PATIENT A HAIR OR SOME SHORT THREAD WAS FOUND WITHIN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 AS "NO PATIENT INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453220 ↗
• MalfunctionNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS BEING USED IN AN UNKNOWN PROCEDURE. THE EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHILE ATTEMPTING TO REMOVE THE IMPLANTED STENT, THE LOOP PART OF THE STENT TORN. THE POLARIS LOOP URETERAL STENT WAS REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO NEW STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10839779 ↗
• MalfunctionNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED IN AN UNKNOWN PROCEDURE. THE EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INSIDE THE PATIENT, THE LOOP PART WAS SEPARATED/BROKEN/DETACHED. REPORTEDLY, THE STENT WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837471 ↗
• MalfunctionMar 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ LOOP URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2017. ON (B)(6) 2017, IT WAS FOUND THAT THE LOOP OF THE STENT MIGRATED IN THE URETHRA. THE PATIENT MANUALLY PULLED OUT THE STENT AND WAS SUCCESSFULLY REMOVED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412194 ↗