GeminiRecalls & reported problems across all models

We found 14 models of Gemini by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Aug 10, 2026 — classified as 13 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Break” (56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Gemini problems

Gemini models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Gemini M0063303060

  DISLODGER, STONE, BASKET, URETERAL, METAL
  29 reports
• Gemini M0063301080

  DISLODGER, STONE, BASKET, URETERAL, METAL
  10 reports
• Gemini M0063301100

  DISLODGER, STONE, BASKET, URETERAL, METAL
  8 reports
• Gemini M0063301090

  DISLODGER, STONE, BASKET, URETERAL, METAL
  6 reports
• Gemini M0063303040

  DISLODGER, STONE, BASKET, URETERAL, METAL
  5 reports
• Gemini M0063303070

  DISLODGER, STONE, BASKET, URETERAL, METAL
  5 reports
• Gemini M0063301040

  DISLODGER, STONE, BASKET, URETERAL, METAL
  5 reports
• Gemini M0063302100

  DISLODGER, STONE, BASKET, URETERAL, METAL
  3 reports
• Gemini M0063301060

  DISLODGER, STONE, BASKET, URETERAL, METAL
  3 reports
• Gemini M0063301110

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 report
• Gemini M0063301070

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 report
• Gemini M0063302060

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 report
• Gemini M0063302080

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 report
• Gemini M0063302110

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 report

Recent Gemini adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 23, 2026Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 11MM GEMINI BASKET DEVICE WAS USED DURING A TRANSURETHRAL BLADDER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE BASKET COULD NOT OPEN AND CLOSE PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED A TEAR AT THE DISTAL END OF THE SHEATH, WHICH CAUSES THE BASKET TO EXIT THE SHEATH BEFORE REACHING THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169296 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A GEMINI BASKET DEVICE WAS ABOUT TO BE USED ON A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. DURING PREPARATION, A PART OF THE BASKET SHEATH RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616886 ↗
• 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 ↗

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