Flexima™ M001272610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729454960), received between Sep 27, 2019 and Mar 27, 2025 — classified as 2 injuries, 3 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.

• MalfunctionMar 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A TEAR IN THE PACKAGING OCCURRED. A 10.3 FLEXIMA DRAINAGE CATHETER WAS USED FOR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) IN THE GALLBLADDER. DURING UNPACKING, IT WAS OBSERVED THAT THERE WAS A TEAR IN THE PACKAGING FROM THE TOP PART AND THE DRAINAGE CATHETER WAS OUT FROM THE TORN PART. THE DEVICE WAS NO LONGER STERILE; THEREFORE, IT WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21711001 ↗
• InjurySep 8, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED RESULTING IN INCREASED PAIN. THE PATIENT WAS UNDERGOING A BILE DUCT DRAINAGE PROCEDURE. A 10F FLEXIMA DRAINAGE CATHETER WAS INSERTED. THE INNER CANNULA AND THE WIRE BECAME STUCK DURING REMOVAL. WHILE ATTEMPTING TO REMOVE THE COMPONENTS, THE CATHETER ACCORDIONED IN THE PATIENT. THE PATIENT EXPERIENCED INCREASED PAIN WHICH WAS MANAGED WITH MIDAZOLAM AND FENTANYL. ADDITIONALLY, HEMATOBILIA WAS OBSERVED DUE TO IRRITATION OF THE BILE DUCT. THE ISSUE OCCURRED WITH TWO CATHETERS. THE DEVICE WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17714320 ↗
• InjurySep 8, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED RESULTING IN INCREASED PAIN. THE PATIENT WAS UNDERGOING A BILE DUCT DRAINAGE PROCEDURE. A 10F FLEXIMA DRAINAGE CATHETER WAS INSERTED. THE INNER CANNULA AND THE WIRE BECAME STUCK DURING REMOVAL. WHILE ATTEMPTING TO REMOVE THE COMPONENTS, THE CATHETER ACCORDIONED IN THE PATIENT. THE PATIENT EXPERIENCED INCREASED PAIN WHICH WAS MANAGED WITH MIDAZOLAM AND FENTANYL. ADDITIONALLY, HEMATOBILIA WAS OBSERVED DUE TO IRRITATION OF THE BILE DUCT. THE ISSUE OCCURRED WITH TWO CATHETERS. THE DEVICE WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17714313 ↗
• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE. UPON PREPARATION OUTSIDE THE PATIENT'S BODY, THE SUTURE OF A 10.3 FLEXIMA DRAINAGE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME SIZE. NO COMPLICATIONS REPORTED AND PATIENT DID WELL.

  Patient problems: No Patient Involvement

  MAUDE report 9145763 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS MISSING A RADIOPAQUE (RO) MARKER ON THE DRAIN. A 10.3 FLEXIMA REGULAR W/RO VTCB WAS SELECTED FOR USE FOR A BILIARY PROCEDURE. IT WAS NOTED THAT THERE WAS RO MARKER ON DRAIN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9129349 ↗