Polaris™ Loop M006155231090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729765493), received between Aug 6, 2021 and Sep 7, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Calcified” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2022Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING A URETERAL STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER. THE EVENT DATE WAS UNKNOWN. DURING A PLANNED STENT REMOVAL PROCEDURE, 4 MONTHS AFTER THE STENT WAS IMPLANTED, IT WAS NOTICED THAT THE STENT WAS CALCIFIED. THE CALCIFIED STENT WAS REMOVED FROM THE PATIENT AND A NEW POLARIS LOOP URETERAL STENT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT REQUIRED REGULAR URETERAL STENT REPLACEMENT DUE TO URETERAL STENOSIS AND WAS ORIGINALLY PRONE TO STONE ADHESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374971 ↗
• InjurySep 7, 2022Calcified; Difficult to Remove; Material Split, Cut or Torn; Calcified; Difficult to Remove; Material Split, Cut or Torn

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2022-04953). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING A URETERAL STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER PERFORMED ON (B)(6) 2022. POST PROCEDURE, ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT IN THE LEFT URETER WITH A PAIR OF BIOPSY FORCEPS, IT WAS FOUND THAT THE STENT WAS CALCIFIED AND THE SHAFT WAS COMPLETELY SEPARATED FROM THE COILS. THE STENT IMPLANTED IN THE RIGHT URETER WAS ALSO ATTEMPTED TO BE REMOVED BUT THERE WAS RESISTANCE AND WAS DIFFICULT TO REMOVE. THE RIGHT URETERAL STENT WAS ALSO FOUND CALCIFIED. THE PATIENT WAS LATER TRANSFERRED TO ANOTHER FACILITY TO PERFORM AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE TO CRUSH THE STONES AND REMOVE THE CALCIFIED STENT THAT WAS LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT REQUIRED REGULAR URETERAL STENT REPLACEMENT DUE TO URETERAL STENOSIS AND WAS ORIGINALLY PRONE TO STONE ADHESION. THE STONE ENCRUSTED TO THE COIL IN THE URETER AND ON THE PELVIC SIDE OF THE RENAL PELVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370468 ↗
• InjurySep 7, 2022Calcified; Difficult to Remove; Material Split, Cut or Torn; Calcified; Difficult to Remove; Material Split, Cut or Torn

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT #3005099803-2022-04961). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING A URETERAL STENT PLACEMENT PROCEDURE IN THE LEFT AND RIGHT URETER PERFORMED ON (B)(6) 2022. POST PROCEDURE, ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT IN THE LEFT URETER WITH A PAIR OF BIOPSY FORCEPS, IT WAS FOUND THAT THE STENT WAS CALCIFIED AND THE SHAFT WAS COMPLETELY SEPARATED FROM THE COILS. THE STENT IMPLANTED IN THE RIGHT URETER WAS ALSO ATTEMPTED TO BE REMOVED BUT THERE WAS RESISTANCE AND WAS DIFFICULT TO REMOVE. THE RIGHT URETERAL STENT WAS ALSO FOUND CALCIFIED. THE PATIENT WAS LATER TRANSFERRED TO ANOTHER FACILITY TO PERFORM AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE TO CRUSH THE STONES AND REMOVE THE CALCIFIED STENT THAT WAS LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT REQUIRED REGULAR URETERAL STENT REPLACEMENT DUE TO URETERAL STENOSIS AND WAS ORIGINALLY PRONE TO STONE ADHESION. THE STONE ENCRUSTED TO THE COIL IN THE URETER AND ON THE PELVIC SIDE OF THE RENAL PELV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370260 ↗
• InjurySep 2, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2021. POST PROCEDURE, IT WAS NOTICED THAT THE STENT WAS COMPLETELY OBSTRUCTING THE RIGHT URETER AT DISTAL END. NO DRAINAGE WAS SEEN AND THE CONTRAST FROM COMPUTERIZED TOMOGRAPHY (CT) 8 HOURS PRIOR, WAS STILL PRESENT AT TIME OF SURGERY. ON (B)(6) 2021, A PROCEDURE WAS PERFORMED TO REMOVE THE POLARIS LOOP URETERAL STENT. THE URETERAL STENT WAS REMOVED IN ITS ENTIRELY AND A 4.8F PERCUFLEX URETERAL STENT WAS IMPLANTED AND SUCCESSFULLY COMPLETED THE PROCEDURE. OBSTRUCTION IN THE URETER WAS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED HAVE FULLY RECOVERED AND TO BE FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12417930 ↗
• MalfunctionAug 6, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A STENT REPLACEMENT PROCEDURE IN THE URINARY TRACT, PERFORMED ON (B)(6) 2021. DURING UNPACKING, THE STENT LOOP WAS FOUND TO BE TORN. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289126 ↗