Polaris™ Ultra M006192132090Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729124436), received between Mar 22, 2018 and Jan 20, 2023 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING PROCEDURE. THE EVENT DATE WAS NOT REPORTED. IT WAS NOTED THAT THE STENT WAS DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS ULTRA 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 AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215586 ↗
• InjurySep 29, 2021Adverse 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 ULTRA URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. POST PROCEDURE, THE PATIENT HAD A DISCOMFORT IN THE BLADDER WAS TRANSMITTED TO THE KIDNEY AND THEN TO THE RECTUM AS A NERVE STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD DYSURIA WHILE USING THE STENT FOR A VERY SHORT PERIOD OF TIME AND AFTER 1 MONTH, BECOMING MORE CONTINUOUS IN A SHORT PERIOD OF TIME. THE STENT WAS SUCCESSFULLY REMOVED AND ALL THE PAIN DISAPPEARED INCLUDING DYSURIA, DISCOMFORT IN KIDNEY, RECTUM AND BLADDER. THERE WERE NO NEW STENTS IMPLANTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Discomfort; Dysuria; Pain; Urinary Retention

  MAUDE report 12546577 ↗
• MalfunctionApr 7, 2021Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A SENSOR GUIDEWIRE WAS INSERTED INTO THE STENT IN ORDER TO PLACE THE STENT. THE GUIDEWIRE COULD NOT BE REMOVED FROM THE STENT, THUS THE STENT COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 SUTURE HOLE TORN, STENT KINKED, AND STENT BUCKLED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628697 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT KIT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE TIP OF THE GUIDEWIRE WAS DETACHED/SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHRINK SLEEVE DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11165340 ↗
• MalfunctionAug 15, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS OPENED FOR USE IN A PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THERE WAS A CRACK/TEAR IN THE PART OF THE OPENING SEAL. THE DEVICE WAS NOT USED. THERE WERE NO PATIENTS OR PROCEDURE INVOLVED IN THIS EVENT. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Patient Involvement

  MAUDE report 7784786 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER THAT WAS INCLUDED IN A POLARIS ULTRA STENT KIT WAS USED DURING AN OPEN UTERINE FIBROID PROCEDURE PERFORMED IN THE URETER ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AXXCESS CATHETER WAS USED FOR MARKING OF THE URETER AND AFTER THE PROCEDURE OF THE UTERINE FIBROID, THE URETERAL CATHETER WAS REMOVED. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DECREASE IN URINATION AND EDEMA WAS OBSERVED IN THE URETERAL ORIFICE. THE PATIENT WAS DIAGNOSED WITH POSTRENAL FAILURE AND A PERCUTANEOUS NEPHROSTOMY PROCEDURE WAS PERFORMED.

  Patient problems: Edema; Renal Failure

  MAUDE report 7704198 ↗
• InjuryJun 13, 2018Break; Calcified; Difficult to Remove; Break; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA STENT WAS REMOVED DURING A URETERAL STENT PLACEMENT PROCEDURE PERFORMED IN THE URETER. THE DATE OF THE PROCEDURE WAS NOT REPORTED. IT WAS REPORTED THAT THE STENT WAS IMPLANTED AROUND (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING STENT REMOVAL, WHICH OCCURRED AROUND (B)(6) 2018, THE STENT WAS FOUND TO BE CALCIFIED. STRONG RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTS WERE MADE TO REMOVE THE CALCIFIED STENT AND THE DISTAL END OF THE STENT DETACHED INSIDE THE KIDNEY. THERE WAS REPORTEDLY A STONE LIKE CORAL ATTACHED TO THE STENT. THE STONE INSIDE THE KIDNEY WAS BROKEN UP AND REMOVED WITH THE USE OF LASER. THE DETACHED STENT PIECE WAS REMOVED BY USING A FLEXIBLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 7596064 ↗
• MalfunctionApr 20, 2018Bent; Kinked; Torn Material; Bent; Kinked; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA STENT WAS REMOVED FROM THE URETER, DURING A PLANNED URETERAL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE STENT WAS IMPLANTED FOR ABOUT TWO WEEKS PRIOR TO REMOVAL. THE STENT WAS PREVIOUSLY IMPLANTED AS PRETREATMENT FOR A PROCEDURE ON THE UPSIDE URETER STONE. ACCORDING TO THE COMPLAINANT, DURING THE REMOVAL PROCEDURE, THE PHYSICIAN NOTICED ON X RAY THAT THE STENT APPEARED TO BE KINKED AND TORN. THE STENT WAS REPORTED TO HAVE RIPPED DURING REMOVAL. THE ENTIRE STENT WAS 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 ¿NO COMPLICATION¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7449233 ↗
• InjuryMar 22, 2018Bent; Calcified; Difficult to Remove; Bent; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS REMOVED DURING A STENT REMOVAL PROCEDURE IN THE URETER. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE RENAL SIDE OF THE PIGTAIL WAS BENT, MAKING IT DIFFICULT TO REMOVE. IT WAS ALSO NOTICED THAT THE STENT WAS CALCIFIED. TO REMOVE THE STENT, TRANSURETHRAL LITHOTRIPSY (TUL) WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 7364751 ↗
• InjuryMar 22, 2018Bent; Calcified; Difficult to Remove; Bent; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS REMOVED DURING A STENT REMOVAL PROCEDURE IN THE URETER. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE RENAL SIDE OF THE PIGTAIL WAS BENT, MAKING IT DIFFICULT TO REMOVE. IT WAS ALSO NOTICED THAT THE STENT WAS CALCIFIED. TO REMOVE THE STENT, TRANSURETHRAL LITHOTRIPSY (TUL) WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 7364704 ↗