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Gemini M0063301070Recalls & reported problems

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729057031), received between Feb 16, 2018 and Feb 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 Component1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GEMINI¿ BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE, PERFORMED ON (B)(6) OF 2017. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT CAME BACK WITH A COMPLAINT OF PAIN. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 AND A YELLOW PLASTIC SHEATH THAT WAS IDENTIFIED TO BE A PART OF A GEMINI¿ BASKET WAS FOUND INSIDE THE URETER. THE SHEATH OF THE BASKET WAS REMOVED, AND A STENT WAS PLACED IN THE PATIENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE SURGERY WAS REPORTED TO BE FINE.

    Patient problems: Pain

    MAUDE report 7278090 ↗

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.