Segura Hemisphere M0063801060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729341901), received between Mar 30, 2018 and Nov 13, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A SEGURA HEMI BASKET DEVICE WAS USED DURING PROCEDURE. DURING THE PROCEDURE, THE SEGURA BASKET BECAME DISTORTED WHILE GRASPING THE URETERAL STONES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED BASKET REVEALED THAT TWO BASKET WIRES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678867 ↗
• MalfunctionJun 26, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET WOULD NOT OPEN AND BROKE. ADDITIONALLY, THERE WAS A STONE INSIDE THE BASKET WHEN IT DID NOT OPEN; HOWEVER, THE STONE WAS RELEASED WHEN THEY TURN THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620089 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET WAS USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STONE, ONE OF THE WIRES IN THE BASKET WAS BROKEN; HOWEVER, THE BROKEN WIRE WAS STILL CONNECTED TO THE END OF THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEGURA HEMI BASKET. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932826 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMI BASKET DEVICE WAS ABOUT TO BE USED IN THE URETER DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE NET GOT FRACTURED. 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 18753392 ↗
• MalfunctionApr 3, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA BASKET HEMI BASKET WAS USED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE BASKET HAD A DETACHED STRAND BEFORE USE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT THE BASKET WIRE WAS STILL ATTACHED TO ONE END. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662638 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS USED IN THE URETER DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BASKET WIRE WAS FOUND BROKEN WHEN THE BASKET WAS PLACED INTO THE ENDOSCOPE AND WAS VISIBLE ON THE MONITOR. THE BASKET WAS REMOVED, AND ANOTHER SEGURA 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 16642840 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE KIDNEY DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RENAL STONE WAS NOTED TO BE TOO HARD AND BROKE THE BASKET WIRE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10769684 ↗
• InjuryDec 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SEGURA HEMISPHERE BASKET BROKE, AND A PIRANHA FORCEPS DEVICE WAS USED TO REMOVE THE BROKEN PIECE. ANOTHER SEGURA BASKET WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9476560 ↗
• MalfunctionOct 10, 2019Break; Difficult to Open or Close; Material Deformation; Material Twisted/Bent; Break; Difficult to Open or Close; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE RETRIEVAL BASKET WAS USED IN A PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SEGURA HEMISPHERE BASKET MALFUNCTIONED. ANOTHER SEGURA HEMISPHERE BASKET WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS REVEALING THE SHEATH WAS TORN AT DISTAL END. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174731 ↗
• MalfunctionMar 30, 2018Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE¿ STONE RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY WITH PLACEMENT OF A DOUBLE J PROBE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SEGURA BASKET WAS INSERTED INTO THE URETER, A PIECE OF THE BASKET GOT STUCK IN THE URETER. A LASER FIBER WAS USED TO CUT THE BASKET AND REMOVE IT FROM THE PATIENT. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385076 ↗