Polaris™ Loop M0061552310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729421078), received between Aug 6, 2020 and Apr 21, 2026 — classified as 1 injury, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY FOR LEFT RENAL CALCULI, A POLARIS URETERAL STENT WAS TO BE USED. AFTER UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947744 ↗
• MalfunctionJan 6, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A URETEROSCOPY PROCEDURE USING A POLARIS LOOP URETERAL STENT, THE LOOP WAS BROKEN WHEN THE PHYSICIAN PUSHED THE DEVICE INTO THE BLADDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983542 ↗
• MalfunctionNov 3, 2025Nonstandard Device; Defective Device; Material Integrity Problem; Material Split, Cut or Torn; Nonstandard Device; Defective Device; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE LOOP WAS ENTANGLED WITH THE SUTURE THREAD CAUSING IT TO BREAK WHILE BEING UNTIED. 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 23459999 ↗
• MalfunctionJul 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LOOP WAS ENTANGLED WITH COTTON THREAD, CAUSING IT TO BREAK WHEN BEING UNTIED. 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 22555173 ↗
• MalfunctionOct 25, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING PREPARATION PRIOR TO TRANSURETEROSCOPIC LITHOTRIPSY, IT WAS NOTICED THAT THE STENT WAS FRACTURED. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533824 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING A STENT PLACEMENT FOR STONE MANAGEMENT, LASER LITHOTRIPSY PROCEDURE IN THE RIGHT URETER ON (B)(6) 2022, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE STENT WAS SUCCESSFULLY IMPLANTED, AND A MEDICATION OF ALPHA BLOCKER, ANTIBIOTIC, AND NARCOTIC ANALGESICS (OPIOIDS) WAS GIVEN FOR THE PATIENT. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND WAS HOSPITALIZED FOR NINE DAYS. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED. THERE WAS NO NEW STENT IMPLANTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 16714282 ↗
• MalfunctionApr 1, 2022Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING AN URETEROSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT WAS STENTED WITH A POLARIS LOOP URETERAL STENT 6X22CM AND FOR AROUND ONE MONTH, A REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVED THE IMPLANTED POLARIS LOOP URETERAL STENT, IT WAS FOUND THAT THE COIL PART MIGRATED TO THE PATIENT'S URETERIC OFFICE. THEY WERE UNABLE TO REMOVE THE MIGRATED COIL WITH FORCEPS, THEREFORE THE PHYSICIAN INSERTED CYSTOSCOPE IN ORDER TO VIEW AND WAS ABLE TO REMOVED THE MIGRATED COIL SUCCESSFULLY. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS "PATIENT DOES NOT FEEL ANY UNUSUAL PAIN". THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981930 ↗
• MalfunctionApr 1, 2022Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS IMPLANTED DURING AN RETROGRADE INTRA RENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS STENTED WITH POLARIS LOOP 6X22CM FOR AROUND 4 DAYS AND A REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVED THE IMPLANTED POLARIS LOOP URETERAL STENT, IT WAS FOUND THAT THE COIL PART MIGRATED TO THE PATIENT'S URETERIC OFFICE. THEY WERE UNABLE TO REMOVE THE MIGRATED COIL WITH FORCEPS, THEREFORE THE PHYSICIAN INSERTED CYSTOSCOPE IN ORDER TO VIEW AND WAS ABLE TO REMOVED THE MIGRATED COIL SUCCESSFULLY. 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 "PATIENT DOES NOT FEEL ANY UNUSUAL PAIN". THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972221 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A LITHOTOMY UNDER URETEROSCOPE PROCEDURE FOR A STONE IN THE URETER, PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE PHYSICIAN NOTICED THAT THE STENT WAS FRACTURED WHEN REMOVED FROM INSIDE THE PATIENT'S BODY. THE FRACTURED STENT WAS PULLED OUT AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. ANOTHER URETERAL STENT WAS IMPLANTED 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 Consequences Or Impact To Patient

  MAUDE report 10375894 ↗