Polaris LoopRecalls & reported problems across all models

We found 12 models of Polaris Loop by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 128 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2017 and Sep 18, 2026 — classified as 1 death, 9 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Break” (63 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Polaris Loop problems

Polaris Loop models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Polaris™ Loop M0061552320

  STENT, URETERAL
  1 death47 reports
• Polaris™ Loop M0061552230

  STENT, URETERAL
  20 reports
• Polaris™ Loop M0061552330

  STENT, URETERAL
  18 reports
• Polaris™ Loop M0061552220

  STENT, URETERAL
  16 reports
• Polaris™ Loop M0061552310

  STENT, URETERAL
  9 reports
• Polaris™ Loop M0061552210

  STENT, URETERAL
  5 reports
• Polaris™ Loop M006155231090

  STENT, URETERAL
  5 reports
• Polaris™ Loop M006155232090

  STENT, URETERAL
  4 reports
• Polaris™ Loop M0061552130

  STENT, URETERAL
  1 report
• Polaris™ Loop M0061552420

  STENT, URETERAL
  1 report
• Polaris™ Loop M0061552110

  STENT, URETERAL
  1 report
• Polaris™ Loop M006155223090

  STENT, URETERAL
  1 report

Recent Polaris Loop adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that a polaris loop ureteral stent was used during bilateral transurethral ureteral/kidney pelvis laser lithotripsy. During preparation, it was found that the double J catheter was fractured. 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 50819544 ↗
• MalfunctionSep 14, 2026Material Split, Cut or Torn

  It was reported that a Polaris Loop Ureteral stent was used in a Retrograde Intrarenal Surgery (RIRS) procedure. During the procedure and inside the patient, it was noticed that the stent was broken. The procedure was completed with another of the same device and there were no patient complications reported. The patient's condition following the procedure was stable.A photo of the complaint device was provided and showed that the stent loops were broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756334 ↗
• 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 ↗
• MalfunctionSep 9, 2026Break

  It was reported that a Polaris Loop Ureteral stent was to be used in Left 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 50682404 ↗
• MalfunctionMay 26, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE DISTAL LOOP OF THE STENT WAS BUCKLED. 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 25294444 ↗
• MalfunctionApr 22, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A RIGID URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE RIGHT RENAL PELVIS. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT WAS BUCKLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956094 ↗
• 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 ↗
• MalfunctionMar 3, 2026Material 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 AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE SUTURE THREAD WAS ENTANGLED TO THE LOOP, CAUSING IT TO BREAK WHEN IT WAS UNTIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492970 ↗
• MalfunctionFeb 19, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY FOR LEFT RENAL CALCULI PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO TWO PARTS. 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 24397434 ↗
• MalfunctionFeb 4, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION FOR A URETEROLITHOTOMY PROCEDURE, A POLARIS URETERAL STENT WAS FOUND TO BE TORN, WITH THE STENT SHAFT BROKEN, PRIOR TO USE. 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 24260352 ↗
• 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 ↗
• MalfunctionJan 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A URETEROSCOPIC STENT PLACEMENT PROCEDURE. DURING UNPACKING, A FLOCCULENT WAS FOUND ON THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981064 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970333 ↗
• MalfunctionDec 2, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT, DURING THE URETEROSCOPY LITHOTRIPSY PROCEDURE RESISTANCE WAS ENCOUNTERED UPON INSERTION OF A POLARIS LOOP URETERAL STENT. THE DEVICE BECAME BLOCKED UPON REACHING THE URETER AND COULD NOT BE ADVANCED FURTHER. THE STENT WAS REMOVED AND FOUND TO BE DEFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME POLARIS LOOP URETERAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701077 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETERAL STENT BREAKAGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS BROKEN. 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 23701030 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports