OLYMPUS NT4F19115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821925041349), received between Mar 16, 2020 and Aug 18, 2026 — classified as 1 injury, 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305577 ↗
• MalfunctionAug 22, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871704 ↗
• MalfunctionNov 2, 2023Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT DURING STONE REMOVAL FROM THE URETER, THE FLEX-CATCH 4 WIRE NITINOL BASKET REMAINED BLOCKED WITH STONE INSIDE. THE PHYSICIAN PROCEEDED TO REMOVE THE STONE VIA LASER PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A FEW MINUTES OF DELAY DEEMED NOT CLINICALLY RELEVANT AND WITH NO HARM TO THE PATIENT OR IMPACT TO THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT; HOWEVER, NO INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055329 ↗
• InjuryAug 24, 2023Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE FLEX-CATCH 4 WIRE NITINOL BASKET WAS BEING USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY WHEN THE DOCTOR NOTICED THE TARGETED STONE WAS TOO LARGE FOR THIS BASKET. THE DOCTOR COULD NOT GET THE BASKET TO RELEASE OR DISLODGE FROM THE URETER. A HOLMIUM LASER WAS USED TO CUT AND RELEASE THE BASKET PRONGS AND GRASPERS WERE USED TO GATHER THE PIECES. AFTER DOING SO, ANOTHER BASKET WAS RETRIEVED AND USED TO COMPLETE THE PROCEDURE. THE PROCEDURE RAN OVER THE SCHEDULED TIME BY 93 MINUTES, BUT IT WAS NOT INDICATED WHETHER THIS DELAY WAS A RESULT OF THE ADDITIONAL MEASURES BEING TAKEN TO REMOVE THE BASKET. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE BASKET NOT RELEASING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618821 ↗
• MalfunctionNov 15, 2022Break; Break

  A QUERY OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FOUND A VOLUNTARY REPORT THAT STATES THE SUBJECT DEVICE BROKE UPON NORMAL URETERAL STONE RETRIEVAL. ACCORDING TO THE REPORT, ALL EQUIPMENT PIECES WERE INTACT AND NO HARM WAS DONE TO THE PATIENT. BECAUSE THE VOLUNTARY REPORT DOES NOT INCLUDE CONTACT INFORMATION FOR THE SUBMITTER, ADDITIONAL INFORMATION CANNOT BE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801180 ↗
• MalfunctionMar 16, 2020Degraded; Difficult to Open or Close

  THE DOCTOR WAS CONDUCTING A BASKET CYSTO URETEROSCOPY LASER STONE EXTRACTION STENT PLACEMENT. THE BASKET MALFUNCTIONED HALFWAY DURING THE CASE AND WILL NOT OPEN AND CLOSE PROPERLY. THE BASKET WAS REPLACED, INCREASING OPERATIVE COST AND TIME, POTENTIALLY PUTTING THE PATIENT AT RISK. ADDITIONALLY, THE LASER FIBER TIP DEGRADED FAR PRIOR TO ITS EXPECTED LIFE. THIS IS A REPEATED PATTERN WITH THIS PRODUCT LINE AND THE COMPANY. MANUFACTURER RESPONSE FOR LASER FIBER, (BRAND NOT PROVIDED) (PER SITE REPORTER). WAITING FOR REPLY FROM SALES MAN. MANUFACTURER RESPONSE FOR STONE RETRIEVAL DEVICE, FLEX CATCH NT 1.9 FR (0.64 MM) X 115 CM (PER SITE REPORTER). THE CLINICIANS CONTACTED THE SALES REP AND WE ARE WAITING FOR A RESPONSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9835107 ↗