Flexima™ APDL M001271310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729323082), received between Oct 29, 2025 and Nov 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Obstruction of Flow; Deformation Due to Compressive Stress; Positioning Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Positioning Problem

  IT WAS REPORTED THAT THE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. A 6 FRENCH FLEXIMA APDL WAS SELECTED FOR USE TO DRAIN A BILIARY ABSCESS. THE DRAINAGE CATHETER WAS INSERTED INTO THE PATIENT, BUT THE DRAIN COULD NOT BE RELEASED. THE PLASTIC CANNULA FOLDED BACK ON ITSELF LIKE AN ACCORDION WHEN THE INTERNAL METAL COMPONENT WAS PULLED. THE DRAIN, THEREFORE, COULD NOT BE USED AS THE LUMEN WAS COVERED BY THE INTERNAL METAL PART. REMOVAL OF THE DRAIN WAS DIFFICULT BECAUSE OF THE ACCORDION LIKE DAMAGE, AND RESULTED IN PAIN DURING REMOVAL. A NEW DRAIN WAS SUCCESSFULLY INSERTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Pain

  MAUDE report 23468127 ↗
• MalfunctionOct 29, 2025Difficult to Insert; Defective Device; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Defective Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15OCT2025. IT WAS REPORTED THAT THE DEVICE DID NOT FUNCTION AS EXPECTED. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE, THE FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS DAMAGED AND DID NOT FUNCTION AS EXPECTED. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE DEVICE MATERIAL SEPARATED AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417252 ↗