Polaris UltraRecalls & reported problems across all models
Boston Scientific Corporation · 40 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 330
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 0
We found 40 models of Polaris Ultra by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 330 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2016 and Sep 30, 2026 — classified as 30 injuries, 300 malfunctions.
The most frequently reported specific device problem is “Break” (157 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
Reports received per month, all models
Most reported Polaris Ultra problems
Device problems
- Break157
- Difficult to Advance61
- Material Deformation47
- Deformation Due to Compressive Stress43
- Material Split, Cut or Torn38
- Adverse Event Without Identified Device or Use Problem33
- Detachment of Device or Device Component32
- Calcified29
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- No Consequences Or Impact To Patient81
- No Known Impact Or Consequence To Patient10
- Discomfort7
- Pain7
- Hematuria3
- Insufficient Information3
- Micturition Urgency3
Polaris Ultra models
40 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Polaris™ Ultra M0061921330STENT, URETERAL71 reports
- Polaris™ Ultra M0061921320STENT, URETERAL64 reports
- Polaris™ Ultra M0061921230STENT, URETERAL62 reports
- Polaris™ Ultra M0061921220STENT, URETERAL20 reports
- Polaris™ Ultra M0061921420STENT, URETERAL14 reports
- Polaris™ Ultra M006192132090STENT, URETERAL10 reports
- Polaris™ Ultra M0061921340STENT, URETERAL9 reports
- Polaris™ Ultra M0061921310STENT, URETERAL8 reports
- Polaris™ Ultra M0061921350STENT, URETERAL8 reports
- Polaris™ Ultra M006192133090STENT, URETERAL7 reports
- Polaris™ Ultra M0061921430STENT, URETERAL7 reports
- Polaris™ Ultra M0061921240STENT, URETERAL4 reports
- Polaris™ Ultra M0061921550STENT, URETERAL4 reports
- Polaris™ Ultra M006193132090STENT, URETERAL4 reports
- Polaris™ Ultra M0061921210STENT, URETERAL3 reports
- Polaris™ Ultra M0061921530STENT, URETERAL3 reports
- Polaris™ Ultra M006192123090STENT, URETERAL2 reports
- Polaris™ Ultra M0061921250STENT, URETERAL2 reports
- Polaris™ Ultra M0061921440STENT, URETERAL2 reports
- Polaris™ Ultra M0061921540STENT, URETERAL2 reports
- Polaris™ Ultra M006193123090STENT, URETERAL2 reports
- Polaris™ Ultra M006193131090STENT, URETERAL2 reports
- Polaris™ Ultra M006192132120STENT, URETERAL2 reports
- Polaris™ Ultra M006192142050STENT, URETERAL2 reports
- Polaris™ Ultra M006192121090STENT, URETERAL1 report
- Polaris™ Ultra M0061921410STENT, URETERAL1 report
- Polaris™ Ultra M006192142090STENT, URETERAL1 report
- Polaris™ Ultra M0061921520STENT, URETERAL1 report
- Polaris™ Ultra M0061921120STENT, URETERAL1 report
- Polaris™ Ultra M0061921130STENT, URETERAL1 report
- Polaris™ Ultra M0061931320STENT, URETERAL1 report
- Polaris™ Ultra M0061931330STENT, URETERAL1 report
- Polaris™ Ultra M006193122090STENT, URETERAL1 report
- Polaris™ Ultra M006193133090STENT, URETERAL1 report
- Polaris™ Ultra M006192133170STENT, URETERAL1 report
- Polaris™ Ultra M006192133180STENT, URETERAL1 report
- Polaris™ Ultra M006192134010STENT, URETERAL1 report
- Polaris™ Ultra M006192133010STENT, URETERAL1 report
- Polaris™ Ultra M006192132050STENT, URETERAL1 report
- Polaris™ Ultra M006192122080STENT, URETERAL1 report
Recent Polaris Ultra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Advance; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949572 ↗MalfunctionSep 29, 2026Break
It was reported that a Polaris Ultra Ureteral stent was used in a procedure. During the procedure, it was noticed that the stent was broken. There was no information on what have completed the procedure and there were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927893 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that a Polaris Ultra Ureteral stent was used in a Retrograde Intrarenal Surgery (RIRS) procedure in the ureter. During procedure and inside the patient, when attempted to cut the suture, the tip at the end broke. The procedure was completed with another of the same device and there were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870663 ↗MalfunctionSep 22, 2026Deformation Due to Compressive Stress; Difficult to Advance
It was reported that a Polaris Ultra Ureteral stent was used in a Flexible Ureteroscopy procedure in the kidney. During insertion, the stent would not advance through the guidewire, and it was noticed that the stent was crumpled. 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 50856103 ↗MalfunctionSep 18, 2026Nonstandard Device; Material Split, Cut or Torn
It was reported that a polaris ultra was used during ureteroscopic lithotripsy. During procedure, it was found that there is a crack at the distal end of DJ stent. 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 50817244 ↗MalfunctionSep 9, 2026Break; Detachment of Device or Device Component
It was reported that a Polaris Ultra Ureteral stent was to be used in a 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 50684087 ↗MalfunctionAug 4, 2026Break
It was reported that a Polaris Ultra ureteral stent was intended for use during a Retrograde Intrarenal Surgery (RIRS) procedure. Upon opening the package and prior to use, the device was found to be broken in the middle. The procedure was completed with another of the same device. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50125458 ↗MalfunctionMay 29, 2026Unsealed Device Packaging
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331591 ↗MalfunctionMay 28, 2026Unsealed Device Packaging
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325165 ↗MalfunctionMay 28, 2026Unsealed Device Packaging
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325158 ↗MalfunctionMay 28, 2026Unsealed Device Packaging
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322704 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE IN THE URETER. 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 25263120 ↗MalfunctionMay 22, 2026Material Deformation
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL SENT WAS USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE END OF THE STENT WAS DIFFERENT FROM THE ORIGINAL SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME MODEL AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260063 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A 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 25108647 ↗MalfunctionApr 15, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTOMY 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 24880945 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page