Segura Hemisphere M0063801070Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729341918), received between May 16, 2019 and Aug 10, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Nonstandard Device; Material Split, Cut or Torn

  It was reported that a Segura Hemi Basket was used during Ureteric stone removal. During procedure, it was observed that a portion of the outer coating/sheath detached from the device and remained within the patient. The coating was retrieved successfully from the patient. The procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196996 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS ABOUT TO BE USED IN A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE. REPORTEDLY, THE PULL WIRE OF THE BASKET WAS OBSERVED BROKEN PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426526 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS USED ON AN UNKNOWN DATE. A SEGURA BASKET BROKE DURING ITS USE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853682 ↗
• MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS TO BE USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, ONE OF THE BASKET WIRES WAS FOUND COMPLETELY DETACHED FROM THE BASKET. ANOTHER SEGURA HEMI BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547201 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHILE USING THE DEVICE TO REMOVE A STONE FROM THE URETER, THE DEVICE TORE. ANOTHER SEGURA BASKET WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092584 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, A WIRE OF THE BASKET WAS TORN. NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. ANOTHER SEGURA BASKET WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092031 ↗
• MalfunctionFeb 18, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE URETER DURING A CYSTOSCOPY LEFT URETEROSCOPY STONE MANIPULATION LASER LITHOTRIPSY BLADDER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED A CRACK AND AN ORANGE SHEET WHEN HE DEPLOYED THE BASKET. THE BASKET WAS REMOVED AND UNDER DIRECT VISUALIZATION, THE DEVICE WAS FOUND INTACT. THE PHYSICIAN WENT BACK TO MAKE SURE THAT NOTHING LEFT BEHIND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT. 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 9722975 ↗
• InjuryMay 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SEGURA BASKET WAS USED TO RETRIEVE A STONE FROM THE URETER. HOWEVER, DURING THE COURSE OF TREATMENT WITH A LASER TRACKING SYSTEM (LTS) LASER, THE BASKET BROKE INTO THREE PIECES IN THE PATIENT'S URETERAL AND BLADDER AREA. ANOTHER SEGURA BASKET WAS USED TO RETRIEVE THE BROKEN PIECES AND COMPLETE THE CASE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615422 ↗