Polaris™ Ultra M006192142050Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent Set · Class 2 · Implant
All models of Polaris Ultra (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729798989), received between Mar 21, 2017 and Dec 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Calcified” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Calcified1
- Deformation Due to Compressive Stress1
- Difficult to Advance1
- Material Integrity Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Deformation Due to Compressive Stress; Difficult to Advance; Material Integrity Problem; Migration; Deformation Due to Compressive Stress; Difficult to Advance; Material Integrity Problem; Migration
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PLACEMENT OF DOUBLE J CATHETER PROCEDURE. DURING INSERTION, IT WAS NOTICED THAT ONE END OF THE CATHETER WAS DAMAGED. IT WAS ALSO REPORTED THAT THE STENT MIGRATED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TARGET ANATOMY LOCATION WAS IN THE URETER, THE STENT COULD NOT MIGRATE FROM THE URETER TO THE KIDNEY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888974 ↗MalfunctionMar 21, 2017Calcified; Calcified
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS¿ ULTRA URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2016 AND WAS REMOVED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINT, DURING STENT WITHDRAWAL, THE STENT WAS NOTED TO BE CALCIFIED. THE PROCEDURE WAS 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 STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6421020 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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