Gemini M0063303040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729074281), received between Sep 17, 2021 and Dec 21, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MINI GEMINI RETRIEVAL BASKET WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE STOP CLOSING; HOWEVER, AFTER CLEANSING, IT STARTED WORKING PROPERLY AGAIN. NO PATIENT COMPLICATIONS HAVE REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS THAT THE BASKET WIRES ARE BROKEN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379324 ↗
• InjurySep 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MINI GEMINI BASKET WAS USED IN THE LEFT URETER DURING A CYSTOSCOPY, URETEROSCOPY, LASER LITHOTRIPSY AND STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2023 DURING THE PROCEDURE, THE BASKET WIRES BROKE IN THE LEFT URETER AROUND URETERAL STONE. IT WAS REPORTED THAT TWO FRAGMENTS OF WIRE FROM BASKET REMAINED IN THE LEFT URETER. ADDITIONALLY, THE PHYSICIAN ATTEMPTED TO REMOVE RETAINED PIECES OF BASKET WITH PIRANHA GRASPING FORCEPS BUT UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER MINI GEMINI BASKET. THE PATIENT EXPERIENCED NARROWING OF URETER WITH MODEST HYDROURETER ABOVE, PYELONEPHRITIS.

  Patient problems: Foreign Body In Patient; Urinary Tract Infection

  MAUDE report 17822272 ↗
• MalfunctionSep 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS TO BE USED IN AN ENDOSCOPIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, WHEN OPENING THE GEMINI EXTRACTOR PACKAGING, THE BASKET WIRES WERE FOUND BROKEN. ANOTHER GEMINI BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417251 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE URETER DURING VIDEO LAPAROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE BASKET WIRE BROKE WHEN THE BASKET WAS OPENED AND CLOSED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362333 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON AUGUST 25, 2021. DURING THE PROCEDURE, THE PULLWIRE AND THE PROXIMAL SECTION OF THE SHEATH WAS BROKEN. NO ADDITIONAL DEVICE WAS REQUIRED TO REMOVED THE SHEATH AND BASKET. ANOTHER GEMINI BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488488 ↗