Flexima™ M001274030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729323785), received between Dec 6, 2024 and Dec 18, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24NOV2025. THE TARGET LESION WAS LOCATED IN THE KIDNEY TO THE BLADDER. A FLEXIMA WAS SELECTED FOR USE. DURING THE PROCEDURE, A HARD RESISTANCE WAS FELT WHEN THE CATHETER WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE SUTURE RETURNED CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843477 ↗
• InjuryOct 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO REMOVE A DRAINAGE CATHETER. A FLEXIMA URETERIC DRAINAGE CATHETER WAS SELECTED FOR USE. THE DRAINAGE CATHETER WAS SUCCESSFULLY INSERTED, HOWEVER, WHEN THE STABILIZER NEEDED TO BE REMOVED, IT BECAME STUCK. WHILE ATTEMPTING TO REMOVE THE STABILIZER, THE ENTIRE DRAINAGE CATHETER STENT WAS MOVING WITH IT AND THE GUIDEWIRE. THE DRAINAGE CATHETER WAS STUCK IN SITU, AND THE PATIENT WAS SENT TO UROLOGY TO HAVE THE DRAINAGE CATHETER REMOVED AND REPLACED WITH ANOTHER DRAINAGE CATHETER, LIKE NEPHROURETERAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429344 ↗
• MalfunctionDec 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE CANNULA AND GUIDEWIRE WERE DIFFICULT TO REMOVE. A FLEXIMA DRAINAGE CATHETER SYSTEM AND AMPLATZ-PI GUIDEWIRE WERE SELECTED FOR USE. DURING AN ANTEGRADE URETERIC STENT STENTING, THE DRAINAGE CATHETER CANNULA WOULD NOT DETACH AND WAS LODGED IN THE DRAINAGE CATHETER STENT. THE AMPLATZ-PI GUIDEWIRE COULD NOT BE REMOVED EASILY, AND REQUIRED EXCESSIVE FORCE TO REMOVE IT. AS A RESULT, THE AMPLATZ-PI GUIDEWIRE FRAYED AND FRACTURED WHEN RETRACTED. THE PATIENT WAS RETURNED TO THE WARD WITH THE STENT IN PLACE WITH THE CANNULA ATTACHED ACTING LIKE THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864250 ↗