Polaris™ Loop M0061552220Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729421023), received between Nov 9, 2017 and Sep 10, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  It was reported that a polaris loop ureteral stent was used during right flexible ureteroscopic lithotripsy. During preparation, it was found that stent was fractured in the middle. The procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707522 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327999 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETERAL LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886509 ↗
• MalfunctionOct 23, 2024Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT COATING WAS FOUND BLISTERED, AND THE SURFACE WAS UNEVEN AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518361 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ENDOSCOPIC URETEROPLASTY PROCEDURE, A POLARIS LOOP URETERAL STENT WAS USED, AND IT WAS FOUND FRACTURED. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750545 ↗
• MalfunctionMay 21, 2024Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A URETEROSCOPY PROCEDURE, THE STENT BECAME BUCKLED AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS LOOP STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363776 ↗
• MalfunctionMar 9, 2023Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS FOUND THAT THE STENT SHAFT WAS FOUND BROKEN. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS BROKEN AND KINKED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518521 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A HOLMIUM LASER LITHOTOMY FOR RIGHT RENAL STONES UNDER FLEXIBLE URETEROSCOPY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2021. DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS FRACTURED IN THE MIDDLE OF THE DEVICE AND COULD NOT BE USED. ANOTHER POLARIS LOOP URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472811 ↗
• MalfunctionApr 12, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A POLARIS LOOP URETERAL STENT WAS USED, DURING A URETERAL STENT IMPLANTATION PROCEDURE IN THE KIDNEY. PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AND INSIDE THE PATIENT. WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT, IT WAS NOTICED, THAT THE STENT WRINKLED. ANOTHER POLARIS LOOP STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649191 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS OPENED TO BE USED DURING A URETERAL STENT IMPLANTATION PROCEDURE IN THE KIDNEY FOR A STONE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PHYSICIAN NOTICED THAT THE STENT WAS BROKEN IN TWO PIECES AND COULD NOT BE USED. ANOTHER POLARIS LOOP 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 10967768 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP STENT WAS USED DURING A LEFT URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE UNPACKING OF THE DEVICE, THE PHYSICIAN FOUND THAT THE STENT SHAFT WAS BROKEN IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105947 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN POLARIS LOOP STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS BROKEN ALONG THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER POLARIS LOOP STENT, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794359 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PHYSICIAN NOTICED THAT THE STENT WAS BROKEN IN TWO ALONG THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP STENT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794131 ↗
• MalfunctionDec 1, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP STENT WAS UNPACKED FOR USE FOR A URETERAL DRAINAGE PROCEDURE TO BE PERFORMED IN THE BLADDER FOR UROLOGIC OBSTRUCTION ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS FRACTURED . THE PROCEDURE WAS COMPLETED USING ANOTHER POLARIS LOOP STENT. THERE WERE NO PATIENT COMPLICATIONS 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8122305 ↗
• MalfunctionOct 25, 2018Break; Calcified; Break; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP STENT WAS REMOVED FROM THE URETER OF A PATIENT DURING A PLANNED LITHOTOMY UNDER FLEXIBLE URETEROSCOPE PROCEDURE PERFORMED ON (B)(6) 2018. THE STENT WAS IMPLANTED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, IT WAS NOTICED THAT THE STENT WAS COVERED WITH STONE. THE ENTIRE STENT WAS REMOVED WITH THE USE OF FORCEPS. AFTER REMOVAL OF THE CALCIFIED STENT, THERE WAS NO NEW STENT IMPLANTED. IT WAS REPORTED THAT ALTHOUGH IT WAS FOUND CALCIFIED, THE STENT WAS ABLE TO DRAIN. THE PATIENT WAS ALSO REPORTED TO HAVE UNDERWENT REGULAR CHECKUPS WITH THE STENT. THERE WERE NO SERIOUS INJURIES NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005416 ↗
• InjuryNov 9, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ LOOP URETERAL STENT WAS IMPLANTED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COIL OF THE STENT DETACHED INSIDE THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS¿ 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 ¿STABLE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7016775 ↗