Gemini M0063301090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729043355), received between Feb 2, 2018 and Mar 23, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A 11MM GEMINI BASKET WAS USED DURING THE PROCEDURE. REPORTEDLY THE FORCEPS BROKE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662370 ↗
• MalfunctionMar 23, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A 11MM GEMINI BASKET WAS USED DURING THE PROCEDURE. REPORTEDLY THE FORCEPS BROKE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660069 ↗
• MalfunctionFeb 20, 2026Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 11MM GEMINI BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT THE ORANGE PROTECTIVE SHEATH SPLIT AND THE BASKET WAS UNABLE TO CLOSE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399917 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT A 11MM GEMINI BASKET DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE HANDLE WAS DYSFUNCTIONAL, AND THE DEVICE DID NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED BASKET IDENTIFIED THE BASKET WAS DETACHED FROM THE PULL WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652385 ↗
• MalfunctionDec 17, 2020Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Material Split, Cut or Torn; Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE KIDNEY DURING A RIGID URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GEMINI BASKET WAS VERY HARD TO OPEN DESPITE SEVERAL MANEUVERS. THE PROCEDURE TIME WAS EXTENDED AS ANOTHER GEMINI BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THAT THE SHEATH WAS TORN AT THE DISTAL END; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11030359 ↗
• MalfunctionFeb 2, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ UROLOGY STONE RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY WITH STONE RETRIEVAL PROCEDURE, PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH BECAME LOOSE AT THE HANDLE. DURING EXTRACTION OF A STONE, THE BASKET¿S SHEATH DETACHED AT THE HANDLE CONNECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI¿ UROLOGY STONE RETRIEVAL 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". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE -BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239132 ↗