Gemini M0063301100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729087427), received between May 23, 2018 and Feb 2, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A TWO 11MM GEMINI BASKET DEVICES WERE SET TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT THE WIRE WAS BROKEN ON EACH BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO 11MM GEMINI BASKET DEVICES THAT WAS SET TO BE USED IN THE SAME PATIENT AND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240842 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT AN 11MM GEMINI BASKET DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT ONE OF THE BASKET WIRES BROKE AND DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832738 ↗
• MalfunctionApr 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 11MM GEMINI BASKET DEVICE WAS ABOUT TO BE USED DURING A PROCEDURE. REPORTEDLY, THE DEVICE WAS DAMAGED UPON UNPACKING. ADDITIONALLY, IT WAS FOUND THAT ONE OF THE WIRES WAS FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21786801 ↗
• MalfunctionAug 22, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS UNPACKED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHEN UNPACKING THE PRODUCT FROM THE BROWN SHIPPING BOX, THE SEAL ON ONE OF THE GEMINI BASKET PACKAGING WAS FOUND TO BE BROKEN AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE DEVICE WAS NOT USED ON A PATIENT OR PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8921095 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET STONE RETRIEVAL WAS USED IN A CYSTOTOMY, URETEROLITHOTOMY WITH DUAL CATHETER AND INSTALLATION J PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTICED THAT THE BASKET WAS BROKEN. THE PROCEDURE WAS COMPLETED ANOTHER GEMINI BASKET. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 Consequences Or Impact To Patient

  MAUDE report 7784742 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ STONE RETRIEVAL BASKET WAS TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WAS FOUND BROKEN WHEN OPENING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 Consequences Or Impact To Patient

  MAUDE report 7574572 ↗
• MalfunctionMay 23, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED IN THE URETER FOR URETERAL LITHOTOMY UNDER RIGID URETEROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE WIRE OF THE BASKET WAS DETACHED. 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 7537340 ↗
• MalfunctionMay 23, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ STONE RETRIEVAL BASKET WAS USED IN THE URETER FOR A URETERAL LITHOTOMY UNDER RIGID URETEROSCOPIC PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE WIRE OF THE BASKET WAS DETACHED. 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 7536851 ↗