OLYMPUS NT4W30115Recalls & reported problems
Gyrus ACMI, LLC · Ultra-Catch NT 3.0 Fr (1.00mm) 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
- 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 00821925027718), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematuria1
- Myocardial Infarction1
- Unspecified Kidney or Urinary Problem1
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED A LITERATURE TITLED "PROGNOSTIC FACTORS FOR THE SAFETY AND EFFICACY OF RETROGRADE LASER LITHOTRIPSY: DATA FROM A CONTEMPORARY SERIES OF 155 CONSECUTIVE PATIENTS WITH SINGLE AND MULTIPLE LITHIASIS OF THE URINARY TRACT". THIS PROSPECTIVE STUDY WAS AIMED TO EVALUATE THE RESULTS AND COMPLICATIONS OF RETROGRADE ENDOSCOPIC LITHOTRIPSY FOR STONES LOCATED IN THE URINARY TRACT AND TO DETERMINE PROGNOSTIC FACTORS FOR TREATMENT OUTCOME. THE PROGNOSTIC FACTORS FOR THE STONE-FREE RATE (SFR) AFTER THE 1ST AND SUBSEQUENT SESSIONS AND OVERALL COMPLICATIONS WERE ASSESSED. PATIENTS WERE DIVIDED INTO SINGLE OR MULTIPLE LITHIASIS GROUPS (GROUPS A AND B RESPECTIVELY). A COMPARISON BETWEEN THESE TWO GROUPS WAS THEN CONDUCTED. OVERALL, 237 STONES WERE DETECTED IN 155 PATIENTS, REPRESENTING A MEAN BURDEN OF 1.53 STONES PER PATIENT. THE MEAN TOTAL STONE SIZE WAS 14.7 MM, THE INITIAL SFR WAS 80% AND THE FINAL SFR (AFTER A MEAN OF 1.23 SESSIONS PER PATIENT) WAS 94.2%. THE RATE OF COMPLICATIONS WAS 26.4%. MULTIVARIATE ANALYSIS REVEALED THAT PREOPERATIVE STENTING AND TOTAL STONE SIZE WERE INDEPENDENT PROGNOSTIC FACTORS OF INITIAL SFR, WHILE NO INDEPENDENT FACTORS WERE DETERMINED FOR FINAL SFR.
Patient problems: Hematuria; Myocardial Infarction; Unspecified Kidney or Urinary Problem; Urinary Tract Infection
MAUDE report 14166810 ↗
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
- 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
- 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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