Gemini M0063303060Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729074304), received between Jun 28, 2017 and Mar 5, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Break; Nonstandard Device; Difficult to Open or Close

  IT WAS REPORTED THAT A GEMINI WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE. PRIOR TO PROCEDURE, IT WAS FOUND THAT THE DEVICE FAILED TO OPEN OR CLOSE AFTER OPENING OUT OF THE BOX. IT APPEARS THAT THE WIRE AT THE RIGHT HANDLE OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525088 ↗
• 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 SECOND 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 24240877 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT TWO MINI-GEMINI BASKETS WERE USED DURING A CALCULUS EXTRACTION PROCEDURE. DURING THE PROCEDURE, WHILE MANEUVERING THE DEVICES, BOTH RETRIEVAL BASKETS BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO MINI-GEMINI BASKETS USED FOR THE SAME PATIENT AND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890018 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT TWO MINI-GEMINI BASKETS WERE USED DURING A CALCULUS EXTRACTION PROCEDURE. DURING THE PROCEDURE, WHILE MANEUVERING THE DEVICES, BOTH RETRIEVAL BASKETS BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO MINI-GEMINI BASKETS USED FOR THE SAME PATIENT AND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890017 ↗
• MalfunctionSep 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AT THE START OF THE LITHIASIS EXTRACTION URETEROSCOPY PROCEDURE USING A GEMINI BASKET, IT WAS NOTICED THAT THE EXTERNAL COATING OF THE BASKET WAS DISLODGED LEADING THE INTERNAL MANDREL VISIBLE. NO PATIENT COMPLICATIONS WERE REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339254 ↗
• MalfunctionSep 11, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT A MINI GEMINI BASKET WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, THE BASKET WAS PUT INTO THE PATIENT; HOWEVER, THE WIRE BASKET WOULD NOT OPEN, AND THE PULL WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190073 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT THREE GEMINI BASKETS WERE USED DURING THE SAME PROCEDURE, AND THE BASKETS WIRES BROKE EITHER BEFORE THE PROCEDURE OR AFTER USE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS REPORT IS FOR THE FIRST OF THE THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924753 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT THREE GEMINI BASKETS WERE USED DURING THE SAME PROCEDURE, AND THE BASKETS WIRES BROKE EITHER BEFORE THE PROCEDURE OR AFTER USE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS REPORT IS FOR THE SECOND OF THE THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924751 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE URETER DURING 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266711 ↗
• MalfunctionAug 12, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE KIDNEY DURING A KIDNEY STONE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A GEMINI BASKET WAS USED IN AN ATTEMPT TO REMOVE KIDNEY STONES. HOWEVER, WHEN STONE WAS CAPTURED AND DEVICE WAS PULLED BACK, THE SHEATH AT THE DISTAL END WAS TORN AND PULL WIRE BROKE. THE STONE INSIDE THE BASKET WAS ABLE TO BE RELEASED AND THE BASKET WAS REMOVED FROM THE PATIENT. 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 15217980 ↗
• MalfunctionAug 12, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE KIDNEY DURING A KIDNEY STONE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A GEMINI BASKET WAS USED IN AN ATTEMPT TO REMOVE KIDNEY STONES. HOWEVER, WHEN STONE WAS CAPTURED AND DEVICE WAS PULLED BACK, THE SHEATH AT THE DISTAL END WAS TORN AND PULL WIRE BROKE. THE BASKET WAS OPENED AND THE STONE WAS REMOVED. THE BASKET WAS REMOVED FROM THE PATIENT. 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 15217968 ↗
• MalfunctionAug 12, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A GEMINI BASKET WAS USED IN AN ATTEMPT TO REMOVE KIDNEY STONES. HOWEVER, WHEN STONE WAS CAPTURED AND DEVICE WAS PULLED BACK, THE SHEATH AT THE DISTAL END WAS TORN AND PULL WIRE BROKE. THE STONE INSIDE THE BASKET WAS ABLE TO BE RELEASED AND THE BASKET WAS REMOVED FROM THE PATIENT. 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 15217807 ↗
• MalfunctionApr 25, 2022Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED IN THE URETER DURING A RIGID URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE GEMINI BASKET WAS TAKEN OUT OF THE PACKAGE AND WAS INSPECTED, THE BASKET WAS FOUND UNABLE TO OPEN AND THE DISTAL END OF THE SHEATH WAS DETACHED. 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 14193293 ↗
• MalfunctionAug 5, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF TWO GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GEMINI BASKETS WERE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO GEMINI BASKETS BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370027 ↗
• MalfunctionAug 5, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF TWO GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GEMINI BASKETS WERE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO GEMINI BASKETS BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369999 ↗
• MalfunctionJul 16, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF THREE GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE GEMINI STONE RETRIEVAL BASKETS WERE USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE WIRES ON THE BASKET BROKE WHILE CAPTURING A STONE. THE SAME ISSUE OCCURRED WITH TWO OTHER BASKETS. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286107 ↗
• MalfunctionJul 16, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF THREE GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE GEMINI STONE RETRIEVAL BASKETS WERE USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE WIRES ON THE BASKET BROKE WHILE CAPTURING A STONE. THE SAME ISSUE OCCURRED WITH TWO OTHER BASKETS. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286105 ↗
• MalfunctionJul 16, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF THREE GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE GEMINI STONE RETRIEVAL BASKETS WERE USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE WIRES ON THE BASKET BROKE WHILE CAPTURING A STONE. THE SAME ISSUE OCCURRED WITH TWO OTHER BASKETS. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286073 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BASKET WAS BROKEN WHEN IT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785409 ↗
• MalfunctionJan 2, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF TWO GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GEMINI BASKETS WERE USED IN A CYSTORETROGRADE LIGHT LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY TOOK THE GEMINI BASKET OUT OF THE PACKAGING, THE END OF THE BASKET WAS FOUND BROKEN. ANOTHER GEMINI BASKET WAS OPENED AND ALSO FOUND THE END BROKEN. THERE WERE NO PATIENT COMPLICATIONS 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 Consequences Or Impact To Patient

  MAUDE report 9539738 ↗
• MalfunctionJan 2, 2020Break; Break

  NOTE: THIS EVENT PERTAINS TO ONE OF TWO GEMINI BASKETS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GEMINI BASKETS WERE USED IN A CYSTORETROGRADE LIGHT LASER PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY TOOK THE GEMINI BASKET OUT OF THE PACKAGING, THE END OF THE BASKET WAS FOUND BROKEN. ANOTHER GEMINI BASKET WAS OPENED AND ALSO FOUND THE END BROKEN. THERE WERE NO PATIENT COMPLICATIONS 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 Consequences Or Impact To Patient

  MAUDE report 9539715 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS PREPPED FOR USE FOR A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT DURING PREPARATION THE DEVICE WAS NOTED TO BE BROKEN OUT OF THE PACKAGE. THE DEVICE WAS NEVER USED IN A PATIENT. 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 Patient Involvement

  MAUDE report 8211972 ↗
• MalfunctionApr 24, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ STONE RETRIEVAL BASKET WAS USED IN A URETERRORENOLITO PLEXIA PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION, THE DEVICE WAS INSERTED INTO THE PATIENT. IT WAS REPORTED THAT THE GEMINI¿ BASKET FAILED TO REMOVE THE STONE. 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 Known Impact Or Consequence To Patient

  MAUDE report 7453830 ↗
• MalfunctionOct 17, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ STONE RETRIEVAL BASKET WAS USED DURING A URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE GEMINI¿ BASKET BROKE AND DID NOT WORK. 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". 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. ADDITIONAL INFORMATION RECEIVED AS OF OCTOBER 17, 2017. IT WAS NOTED THAT THE BASKET WAS UNABLE TO OPEN AND ONE OF THE BASKET WIRE WAS BROKEN. ADDITIONALLY, THE BROKEN BASKET WIRE IS STILL ATTACHED AT ONE END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6955509 ↗
• MalfunctionJun 28, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED FOR A RIGID URETEROSCOPY PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PULL WIRE OF THE GEMINI STONE RETRIEVAL BASKET BROKE, AND WAS UNABLE TO OPEN. 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 "NORMAL". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6673724 ↗