Segura Hemisphere M0063801100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729341925), received between Jan 7, 2021 and Sep 15, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET DEVICE WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE BASKET WIRE WAS COMPLETELY DETACHED FROM ITS TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEGURA HEMI BASKET DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757124 ↗
• InjuryJun 8, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BASKET WAS DEPLOYED IN THE KIDNEY AND CAPTURED A STONE. HOWEVER, THE STONE WAS TOO LARGE TO REMOVE THROUGH THE URETER. THE BASKET WAS ATTEMPTED TO OPEN TO RELEASE THE STONE BUT IT FAILED TO OPEN. A HOLMIUM LASER WAS USED TO DISMANTLE THE BASKET AND SUCCESSFULLY RELEASED THE STONE. THE BASKET WAS THEN REMOVED AND THE STONE WAS FRAGMENTED. ANOTHER SEGURA HEMI BASKET WAS USED TO REMOVED THE STONE FRAGMENTS AND COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636586 ↗
• InjurySep 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS THAT A SEGURA HEMI BASKET WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DISTAL END OF THE SHEATH DETACHED INSIDE THE PATIENT. THE DETACHED SHEATH WAS RETRIEVED USING A FOREIGN BODY CLAMP. PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519087 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE RETRIEVAL BASKET WAS USED IN A CYSTOSCOPY, LASER LITHOTRIPSY, AND BASKET EXTRACTION OF BLADDER STONE PROCEDURE PERFORMED IN (B)(6) 2020. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN. THE SEGURA BASKET WAS USED ONCE AND THE WIRE BROKE OUT OF SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 11330095 ↗
• MalfunctionJan 8, 2021Break; Defective Device

  DEFECTIVE SEGURA BASKET. USE ONCE AND WIRE BROKE OUT OF SHEATH. PRODUCT SAVED FOR QUALITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139096 ↗
• MalfunctionJan 7, 2021Defective Device

  BASKET NOT FUNCTIONAL UPON REMOVING FROM PACKAGE.

  Patient problems: Insufficient Information

  MAUDE report 11130729 ↗