Polaris™ Ultra M006193133090Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729762928), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Calcified1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Split, Cut or Torn1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2021Calcified; Difficult to Remove; Obstruction of Flow; Detachment of Device or Device Component; Material Split, Cut or Torn; Calcified; Difficult to Remove; Obstruction of Flow; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PROCEDURE DUE TO PYELONEPHRITIS IN THE URINARY TRACT, PERFORMED ON AN UNKNOWN DATE IN (B)(6) HOSPITAL. DURING A URETERAL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, FIVE MONTHS AFTER THE STENT WAS IMPLANTED, THE STENT COULD NOT BE REMOVED. THE PATIENT WAS REFERRED TO (B)(6) HOSPITAL AND WAS CHECKED UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE PIGTAIL COIL ON THE KIDNEY SIDE WAS DETACHED IN THE URETER. A GUIDEWIRE WAS TRIED TO ADVANCE, BUT IT COULD NOT ADVANCE. THE STENT WAS REMOVED WHILE FOLLOWING THE URETERAL ACCESS SHEATH. ANOTHER URETERAL STENT OF A DIFFERENT MODEL WAS USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT WAS CALCIFIED AND THE PIGTAIL WAS DETACHED/SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185420 ↗
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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