OLYMPUS NTCP22115Recalls & reported problems
Gyrus ACMI, LLC · X-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval Device · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00821925027695), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2021Break; Break
UPDATES FROM CUSTOMER RESPONSE ON EVENT/PROBLEM REPORTED : THE BASKET WOULD NOT OPEN. ANOTHER BASKET WAS USED AND THE INTENDED PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450250 ↗
Other DISLODGER, STONE, FLEXIBLE devices
- Stone Cone M0063903200Boston Scientific Corporation · DISLODGER, STONE, FLEXIBLE87 reports
- Stone Cone M0063903100Boston Scientific Corporation · DISLODGER, STONE, FLEXIBLE21 reports
- OLYMPUS NT4F19115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE6 reports
- OLYMPUS NT4W18115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE4 reports
- GYRUS ACMI 5711012Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE2 reports
- OLYMPUS NT4W22115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE2 reports
- GYRUS ACMI 5710009Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE1 report
- OLYMPUS NT4W30115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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