Gemini M0063301040Recalls & reported problems
Boston Scientific Corporation · Paired Wire Helical Stone Retrieval Basket · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729087397), received between May 1, 2017 and Jan 23, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Contamination with Chemical or Other Material1
- Difficult to Open or Close1
- Difficult to Remove1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Difficult to Open or Close; Material Split, Cut or Torn
IT WAS REPORTED THAT A 11MM GEMINI BASKET DEVICE WAS USED DURING A TRANSURETHRAL BLADDER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE BASKET COULD NOT OPEN AND CLOSE PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED A TEAR AT THE DISTAL END OF THE SHEATH, WHICH CAUSES THE BASKET TO EXIT THE SHEATH BEFORE REACHING THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24169296 ↗MalfunctionApr 3, 2023Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN A PROCEDURE. DURING PROCEDURE, A GEMINI BASKET WAS USED IN AN ATTEMPT TO REMOVE THE CALCULUS FRAGMENT AFTER IT HAD PARTLY FRAGMENTED. HOWEVER, WHEN THE CALCULUS FRAGMENT WAS TAKEN OUT, IT SLID. UPON INSPECTION, THE LATERAL ROD OF THE EXTRACTOR HAD A BREAK. THE REMAINING CALCULUS PIECES WERE REMOVED USING A SECOND GEMINI BASKET. THERE WERE NO PATIENT COMPLICATIONS 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663016 ↗InjuryDec 6, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE URETER DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE GEMINI BASKET WAS INSERTED IN THE URETER, HOWEVER, THE BASKET GOT STUCK IN BETWEEN THE STONES AND WAS DIFFICULT TO REMOVE. THE BASKET WAS INTENTIONALLY BROKEN AND PULLED OUT, THAT CAUSED SOME BLEEDING. THERE WAS NO STONE INSIDE THE BASKET WHEN IT GOT STUCK. THERE WAS NO TREATMENT PERFORMED FOR THE BLEEDING. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15924059 ↗MalfunctionSep 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS TO BE USED FOR A PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS FOUND IN THE PACKAGING. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7903875 ↗MalfunctionMay 1, 2017Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED IN THE ESOPHAGUS DURING A BRONCHOSCOPY PROCEDURE TO REMOVE A FOREIGN BODY THAT WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE & OUTSIDE THE PATIENT, IT WAS FOUND THAT PULL WIRE WAS BROKEN WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. 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 FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6535888 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
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- 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.