Polaris™ Loop M0061552110Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
All models of Polaris Loop (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729765349), received between Nov 20, 2017 and Nov 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 16, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP WAS USED FOR A STENT REPLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, SEVERAL WEEKS POST STENT PLACEMENT, THE POLARIS LOOP STENT HAD MIGRATED. IT HAD SLID OUT OF THE KIDNEY AND WENT TOO FAR INTO THE URETER AND WAS REMOVED ENTIRELY WITH THE USE OF FORCEPS. THE PATIENT HAD TO HAVE A NEW STENT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND 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 7047101 ↗
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 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