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NCircle G18191Recalls & reported problems

Cook Incorporated · NCircle, Nitinol Tipless Helical Stone Extractor · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002181915), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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

  • Difficult to Open or Close1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 2, 2017Difficult to Open or Close; Difficult to Open or Close

    THE USER FACILITY REPRESENTATIVE REPORTED, DURING AN URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE WHEN THE PHYSICIAN TRIED TO USE THE NCIRCLE HELICAL TIPLESS STONE EXTRACTOR TO GRAB THE STONE, THE BASKET WOULDN'T CLOSE. A NEW BASKET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT BECAUSE OF THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6906761 ↗

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.