Gemini M0063302100Recalls & reported problems
Boston Scientific Corporation · Paired Wire Helical Stone Retrieval Basket · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729069713), received between Nov 10, 2017 and Nov 6, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT A GEMINI BASKET DEVICE WAS ABOUT TO BE USED ON A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. DURING PREPARATION, A PART OF THE BASKET SHEATH RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616886 ↗InjuryAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 14MM GEMINI BASKET WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A STONE WAS CAPTURED WITH A GEMINI BASKET. WHILE PULLING OUT THE BASKET, A PART OF THE BASKET GOT STUCK IN THE URETER. THE STUCK PART WAS GRABBED WITH A PAIR OF PLIERS AND PULLED OUT. THE REPORTER STATED THAT THE DISTAL PART OF THE BASKET ASSEMBLY (PULL WIRE WITH BASKET) WAS BROKEN AND DETACHED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17614070 ↗MalfunctionNov 10, 2017Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PULL WIRE BROKE LEAVING THE BASKET STUCK INSIDE THE PATIENT. THERE WAS NO STONE INSIDE THE BASKET WHEN THE PULL WIRE BROKE. THE PHYSICIAN PULLED THE BASKET HARD TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI 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 Consequences Or Impact To Patient
MAUDE report 7017758 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.