OLYMPUS NT4W22115Recalls & reported problems
Gyrus ACMI, LLC · Ultra-Catch NT 2.2 Fr (0.73mm) x 115cm Stone Retrieval Device · Class 2
All models of Olympus (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925027701), received between Sep 15, 2025 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- No Device Output1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290677 ↗MalfunctionSep 15, 2025No Device Output
OLYMPUS ULTRA-CATCH NT- NO TIP NITINOL BASKET DOESN'T WORK.
Patient problems: Insufficient Information
MAUDE report 23050530 ↗
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
- GYRUS ACMI 5710009Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE1 report
- OLYMPUS NT4W30115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE1 report
- Talon 00711175US Endoscopy · 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page