Gemini M0063303070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729074311), received between Jan 27, 2022 and Jul 4, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJul 4, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A MINI-GEMINI BASKET WAS USED DURING A LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BASKET AND GRABBED THE STONE; HOWEVER, WHEN THEY TRIED TO RETRACT AND OPEN THE BASKET IT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677085 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE URETER ON A URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE WIRE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232215 ↗
• InjuryAug 9, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE PROXIMAL URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. PRIOR TO INSERTION, THE GEMINI BASKET WAS INSPECTED AND FOUND THE BASKET WOULD OPENED AND CLOSED. THE GEMINI BASKET WAS THEN INSERTED AND CAPTURED A STONE. HOWEVER, THE BASKET FAILED TO OPEN TO RELEASE THE STONE. THE HANDLE WAS DISMANTLED AND THE BASKET CAGE WAS BROKEN OFF TO RELEASED THE STONE. A DIFFERENT DEVICE 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 15191312 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS TO BE USED IN THE URETER DURING A STONE REMOVAL PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, WHEN THE GEMINI BASKET WAS TAKEN OUT OF THE PACKAGE AND WAS INSPECTED, THE SHEATH WAS FOUND BROKEN. A PHOTO OF THE COMPLAINT DEVICE SUBMITTED BY THE CUSTOMER SHOWED THE SHEATH WAS BROKEN ON THE DISTAL END. 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 14546641 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS TO BE USED IN THE KIDNEY ON A STONE RETRIEVAL PROCEDURE ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE GEMINI BASKET WAS UNPACKED AND FOUND THE BASKET WIRE WAS BROKEN. THE PROCEDURE WAS CANCELLED AND RESCHEDULED ON UNKNOWN DATE SINCE THERE WAS NO MORE BASKET AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369000 ↗