Skip to content

Gemini M0063301060Recalls & reported problems

Boston Scientific Corporation · Paired Wire Helical Stone Retrieval Basket · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729087403), received between Mar 29, 2017 and Mar 22, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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

Device problems

  • Detachment of Device or Device Component2
  • Device Contaminated During Manufacture or Shipping1
  • Device Contamination with Chemical or Other Material1

Patient problems

  • Insufficient Information1
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. A PIECE OF THE GEMINI BASKET BROKE INTO THE PATIENTS URETER. THE BROKEN PIECE WAS SUCCESSFULLY RECOVERED USING A MULTI-USE BASKET DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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: Insufficient Information

    MAUDE report 11547748 ↗
  • MalfunctionJan 6, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI STONE RETRIEVAL BASKET WAS UNPACKED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, TWO SMALL PARTICLES WERE NOTICED IN THE STERILE PACKAGING OF THE GEMINI BASKET. THERE WERE NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 9554072 ↗
  • InjuryMar 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ UROLOGY STONE RETRIEVAL BASKET WAS USED DURING AN URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED USING FORCEPS. 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 6443015 ↗

Other DISLODGER, STONE, BASKET, URETERAL, METAL devices

All DISLODGER, STONE, BASKET, URETERAL, METAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.