Flexima™ M001274120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729323860), received between Dec 2, 2022 and Jul 7, 2026 — classified as 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. THE TARGET LOCATION WAS THE URETER. DURING PLACEMENT OF A FLEXIMA URETERAL STENT FOR TREATMENT OF URETERAL OBSTRUCTION, MILD RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. DURING THE DEPLOYMENT PHASE, THE STENT FAILED TO FULLY DEPLOY AND WAS PARTIALLY DEPLOYED. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT DIFFICULTY. NO DEVICE DAMAGE OR KINKING WAS OBSERVED. NO PATIENT OR ANATOMICAL COMPLICATIONS WERE REPORTED, NO ADDITIONAL INTERVENTION WAS REQUIRED, AND THE PATIENT REMAINED STABLE WITH NO REPORTED ADVERSE OUTCOME. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740368 ↗
• MalfunctionFeb 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A FLEXIMA DRAINAGE CATHETER SYSTEM KIT WAS SELECTED FOR BILIARY DRAINAGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN NORMAL CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327938 ↗
• MalfunctionJan 30, 2023Break; Break

  IT WAS REPORTED THAT THE THREAD GOT BROKEN. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE THREAD WAS BROKEN UPON SETTING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16266935 ↗
• MalfunctionDec 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A DEVICE DISLODGEMENT OCCURRED. A FLEXIMA DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE FLEXIMA DEVICE IN A 7FR GUIDE CATHETER. AS HE PUSHED THE FLEXIMA DEVICE WITH THE PUSHER, A SLIGHT RESISTANCE WAS FELT. IT WAS NOTED THAT THE RADIOPAQUE RING OF THE PUSHER DISLODGED, AND THE HEALTHCARE PROFESSIONAL WAS ABLE TO RETRIEVE IT IN THE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053110 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT SUTURE BREAK OCCURRED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. A FLEXIMA DRAINAGE CATHETER SYSTEM KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE DRAINAGE CATHETER WAS INSERTED INTO THE PATIENT, WHEN THE PHYSICIAN TRIED TO MAKE A LOOP, IT WAS NOTED THAT THE SUTURE DISCONNECTED FROM THE DRAINAGE CATHETER. THE DRAINAGE CATHETER WAS SIMPLY PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905088 ↗