OLYMPUS NT4W18115Recalls & reported problems
Gyrus ACMI, LLC · Ultra-Catch NT 1.8 Fr (0.60mm) 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925027725), received between Aug 8, 2023 and Feb 5, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
- Loose or Intermittent Connection1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Break
IT WAS REPORTED THE ULTRA-CATCH NT STONE RETRIEVAL DEVICE WAS BROKEN WHEN DEPLOYED. THE ISSUE OCCURRED DURING A THERAPEUTIC URETHROSCOPY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269351 ↗MalfunctionOct 24, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382472 ↗MalfunctionJul 23, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED, THE STONE RETRIEVAL DEVICE'S WIRE CAME LOOSE FROM THE BASE. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL LITHOTRIPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE INTENDED PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805032 ↗MalfunctionAug 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A USER FACILITY REPORTED TO OLYMPUS UPON OPENING THE BOX AND CHECKING THE ACTUAL PRODUCT, THE BASKET WIRE WAS CUTE. THE THERAPEUTIC TRANSURETHRAL LITHOTRIPSY PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480463 ↗
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 NT4W22115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE2 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.
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