Polaris™ Ultra M0061921210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729124283), received between Apr 14, 2017 and Aug 18, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIETIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS OPEN TO BE USED DURING A STENT EXCHANGE PROCEDURE PERFORMED IN THE RIGHT URETER ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE THE PATIENT, WHEN THE SUTURE WAS REMOVED, THE LOWER SEGMENT OF THE STENT SHAFT BROKE. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420956 ↗
• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE DEVICE WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A USE OF ANOTHER POLARIS ULTRA STENT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS 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. CORRECTED INFORMATION RECEIVED ON 08AUG2019. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874747 ↗
• MalfunctionApr 14, 2017Device Packaging Compromised; Device Packaging Compromised

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2017-01135 AND MFR. REPORT # 3005099803-2017-01136). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT AND AN ASCERTA STENT WERE MEANT TO BE USED FOR A CYSTO STENT EXCHANGE PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED DURING PREPARATION FOR THE PROCEDURE THAT THE INNER BOX CONTAINING THE STERILE DEVICE WAS CRUMPLED ON THE CORNER. REPORTEDLY, IT WAS ASSUMED THAT THE STERILITY OF THE PRODUCT WAS COMPROMISED. HOWEVER, THE INNER BOX WAS NOT OPENED TO CHECK THE STERILE POUCH CONTAINING THE DEVICE. IT IS UNKNOWN IF THE OUTER SHIPPING BOX WAS DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494661 ↗