Skip to content

Segura Hemisphere M0063801180Recalls & reported problems

Boston Scientific Corporation · Stone Retrieval Basket · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729341970), received between May 4, 2018 and Jun 3, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Device Contamination with Chemical or Other Material1
  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 3, 2020Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS TO BE USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE HANDLE WAS TO BE SEPARATED DURING USE, THE INNER CORE OF THE BASKET WAS CROOKED, RESULTING IN POOR SEPARATION. A PHOTO OF THE COMPLAINT DEVICE SUBMITTED BY THE CUSTOMER SHOWS THE PULL WIRE BROKEN ON THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEGURA HEMI BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10114021 ↗
  • MalfunctionAug 19, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS USED IN A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A BROWN STAIN WAS FOUND INSIDE THE CAP OF THE HANDLE AND WAS CONFIRMED BY A PHOTOGRAPH SENT FROM THE CUSTOMER. IT WAS NOTED THAT THERE WAS NO DAMAGED TO THE PACKAGING. ANOTHER SEGURA BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8906196 ↗
  • MalfunctionMay 4, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE¿ BASKET WAS USED IN THE KIDNEY FOR A STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SEGURA BASKET WAS ACTUATED INSIDE THE PATIENT, THE PULL WIRE BROKE. THE BASKET WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS EXTENDED FOR ABOUT 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7488606 ↗

Other DISLODGER, STONE, BASKET, URETERAL, METAL devices

All DISLODGER, STONE, BASKET, URETERAL, METAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.