Segura Hemisphere M0063801120Recalls & reported problems
Boston Scientific Corporation · Stone Retrieval Basket · Class 2
All models of Segura Hemisphere (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729341949), received between Dec 7, 2016 and Feb 9, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
- Detachment of Device or Device Component4
- Material Split, Cut or Torn2
- Torn Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS SET TO BE USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, BEFORE THE SURGERY, IT WAS FOUND THAT THE BASKET HANDLE COMPONENT FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT ONE OF THE BASKET WIRES WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299742 ↗MalfunctionSep 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, DURING UNPACKING IT WAS FOUND THAT THE BASKET HANDLE COMPONENT FALLS OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT ONE OF THE BASKET WIRES WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064480 ↗MalfunctionJul 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A SEGURA HEMI BASKET WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, BEFORE THE PROCEDURE, IT WAS FOUND THAT THE BASKET HANDLE COMPONENT FALLS OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT ONE OF THE BASKET WIRES WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449363 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT A SEGURA HEMI BASKET DEVICE WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE BASKET CAN'T BE WORKED. ADDITIONALLY, IT WAS NOTICED THAT ONE OF THE BASKET WIRES GOT DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21986451 ↗MalfunctionMar 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, THE BASKET HANDLE COMPONENT FALLS OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT ONE OF THE BASKET WIRES WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713618 ↗MalfunctionMar 17, 2022Material 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 RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SHEATH WAS TORN ON THE DISTAL SECTION. 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 FOLLOWING PROCEDURE IS REPORTEDLY STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13792481 ↗MalfunctionJan 13, 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 A URETEROSCOPY (URS) PROCEDURE. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN BUT WAS REPORTED TO BE EITHER (B)(6) 2019 OR (B)(6) 2019. PRELIMINARY INVESTIGATION OF THE DEVICE FOUND THAT THE SHEATH WAS TORN AT THE DISTAL END. 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 Known Impact Or Consequence To Patient
MAUDE report 9582843 ↗MalfunctionNov 8, 2019Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AT THE TIME OF STONE CAPTURE, THE BASKET WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS 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 Consequences Or Impact To Patient
MAUDE report 9296541 ↗MalfunctionDec 7, 2016Torn Material; Torn Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE¿ BASKET WAS USED IN THE BILIARY TRACT DURING STONE MANAGEMENT PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BASKET WAS UNABLE TO OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEGURA HEMISPHERE¿ 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE SHEATH WAS FOUND TORN AT THE DISTAL END.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6153230 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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