Segura HemisphereRecalls & reported problems across all models
Boston Scientific Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 7 models of Segura Hemisphere by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Aug 10, 2026 — classified as 5 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Break” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Segura Hemisphere problems
Device problems
- Break26
- Material Split, Cut or Torn6
- Detachment of Device or Device Component5
- Difficult to Open or Close5
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
Segura Hemisphere models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Segura Hemisphere M0063801060DISLODGER, STONE, BASKET, URETERAL, METAL10 reports
- Segura Hemisphere M0063801120DISLODGER, STONE, BASKET, URETERAL, METAL9 reports
- Segura Hemisphere M0063801070DISLODGER, STONE, BASKET, URETERAL, METAL8 reports
- Segura Hemisphere M0063801100DISLODGER, STONE, BASKET, URETERAL, METAL6 reports
- Segura Hemisphere M0063801180DISLODGER, STONE, BASKET, URETERAL, METAL3 reports
- Segura Hemisphere M0063801000DISLODGER, STONE, BASKET, URETERAL, METAL2 reports
- Segura Hemisphere M0063801020DISLODGER, STONE, BASKET, URETERAL, METAL2 reports
Recent Segura Hemisphere adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 15, 2023Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA HEMISPHERE BASKET WAS USED IN THE LEFT KIDNEY DURING PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING PROCEDURE, THE DISTAL SECTION OF THE SHEATH WAS MELTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEGURA HEMISPHERE BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550084 ↗InjuryApr 18, 2023Difficult to Remove; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEGURA BASKET WAS USED IN THE URETER DURING A CYSTOSCOPY/URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE DEVICE BECAME LODGED AND STUCK IN THE PATIENT'S BODY. A SECOND PROCEDURE WAS REQUIRED TO REMOVE THE DEVICE ON AN UNKNOWN DATE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762645 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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