Gemini M0063301080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729087410), received between Dec 21, 2016 and Aug 10, 2026 — classified as 4 injuries, 6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break; Difficult to Open or Close

  It was reported that a Gemini basket was used during a Rigid laser Ureterorenolithotripsy (URSL) procedure. During the procedure, the basket jammed during opening and closing attempts. However, when they try opening it again the basket broke near the junction and it was impossible to retrieve the basket. The procedure was completed with another of the same device with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196997 ↗
• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET RETRIEVAL WAS USED IN THE KIDNEY DURING ENDOSCOPIC BASKET LITHOTOMY PROCEDURE PERFORMED ON (B)(4) 2023. DURING THE PROCEDURE, WHEN THE BASKET CAPTURED THE STONE, THE BASKET WIRE WAS FRACTURED; HOWEVER, THE BASKET WIRE DID NOT COMPLETELY DETACH FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261502 ↗
• InjuryAug 16, 2022Break; Use of Device Problem; Difficult to Open or Close; Break; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BASKET WAS INSERTED INTO THE PATIENT, THE HANDLE WAS ACTUATED BUT THE BASKET FAILED TO OPEN. THE BASKET WAS TESTED OUTSIDE OF THE PATIENT AND FOUND IT WOULD WORK . THE BASKET INSERTED BACK INTO THE PATIENT AND CAPTURED A STONE. HOWEVER, THE BASKET STOPPED RESPONDING WHEN THE HANDLE WAS ACTUATED AND STARTED UNRAVELING. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO GET THE BASKET TO OPEN BUT FAILED. THE BASKET WAS STARTING TO GRAB URETERAL TISSUE AND WOULD NOT OPEN. WHEN THE BASKET WITH THE STONE WAS PULLED OUT, THE URETER DISCONNECTED FROM THE BLADDER. SURGERY WAS PERFORMED TO RECONNECT THE URETER TO THE BLADDER.

  Patient problems: Insufficient Information

  MAUDE report 15232209 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS USED IN A URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WIRE BROKE BUT IS STILL ATTACHED TO THE BASKET AT ONE END. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTEDLY STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649972 ↗
• MalfunctionJul 31, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED IN A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, UPON OPENING THE BASKET, THE SHEATH WAS NOTED TO BE BROKEN. PRELIMINARY INVESTIGATION OF THE DEVICE FOUND THAT THE SHEATH WAS TORN ON THE DISTAL END. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO 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 Known Impact Or Consequence To Patient

  MAUDE report 8847750 ↗
• MalfunctionJul 17, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS TO BE USED FOR A TRANSURETHRAL LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS UNPACKED AND A LONG HAIR WAS FOUND INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER GEMINI BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798966 ↗
• InjurySep 27, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN A PATIENT ON (B)(6) 2018. THE PATIENT HAD UNDERGONE CYSTOURETHROSCOPY WITH URETHRAL CALIBRATION/DILATION; RIGHT RETROGRADE PYELOURETEROGRAM; RIGHT RIGID URETEROSCOPY WITH HOLMIUM LASER ABLATION OF STONE; AND PLACEMENT OF RIGHT DOUBLE J URETERAL STENT. DURING THE PROCEDURE, RETROGRADE WAS PERFORMED IN THE RIGHT ORIFICE AND SHOWED A FILLING DEFECT CONSISTENT WITH STONE IN MID URETER RIGHT AT THE LEVEL OF SPINAL HARDWARE. THERE WAS DILATION OF URETER AND PYELOCALICEAL SYSTEM PROXIMALLY. A GUIDEWIRE WAS NEGOTIATED UP TO THE RIGHT KIDNEY AND WAS ENGAGED IN THE GEMINI BASKET TO KEEP STONES FROM REFLUXING BACK INTO THE KIDNEY WHILE UNDERGOING LASER TREATMENT. THIS AREA OF THE URETER WAS ADJACENT TO THE SCARRING FROM THE BACK HARDWARE AND WAS VERY IMMOBILE AND DID NOT DILATE EASILY. NUMEROUS SMALL STONE FRAGMENTS WERE ABLATED. THE UPPER PART OF THE STONES AND THE BASKET WERE DIFFICULT TO REACH AND DURING THE PROCESS OF LASERING THE STONE, SOME OF THE FIBERS OF THE BASKET WERE TRANSECTED LEAVING FRAGMENTS IN THE URETER WITH SOME RESIDUAL STONE. THE BASKET FRAGMENTS AND RESIDUAL STONE WERE LEFT IN THE URETER. A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7913837 ↗
• MalfunctionJun 15, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP¿ STONE RETRIEVAL BASKET WAS TO BE USED FOR A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PACKAGING OF THE DEVICE WAS FOUND TO BE DIFFICULT TO OPEN, WHICH MAY HAVE LED TO COMPROMISING THE STERILITY OF THE DEVICE INSIDE THE POUCH. 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 7607960 ↗
• InjuryDec 18, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI BASKET WAS USED IN THE KIDNEY DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PROXIMAL METAL TIP WAS DETACHED FROM THE DEVICE AND REMAINED INSIDE THE KIDNEY. THE PROCEDURE WAS EXTENDED FOR TWENTY MINUTES TO SUCCESSFULLY RETRIEVE THE DETACHED METAL TIP. 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 7127741 ↗
• InjuryDec 21, 2016Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WIRE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED USING BIOPSY CUPS. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6196523 ↗