Flexima™ APDL M001275010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729300670), received between Aug 24, 2021 and Dec 19, 2025 — classified as 3 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. How this data works · Data updated Oct 13, 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 19, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 7.3 FLEXIMA ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DAMAGED DURING ATTEMPTED PLACEMENT OVER THE GUIDEWIRE. A TEAR OCCURRED ON THE DISTAL SIDE OF THE STENT, ALLOWING THE GUIDEWIRE TO EXIT THROUGH THE SIDE OF THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853477 ↗
• MalfunctionOct 21, 2024Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 25SEP2024. IT WAS REPORTED THAT THE STENT WAS DETACHED IN THE PROXIMAL SECTION. AN APDLTL/7.3 FLEXIMA ALL-PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS RESISTANCE DURING STENT DEPLOYMENT, AND THE SHEATH COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, PRODUCT INVESTIGATION REVEALED THAT STENT ALSO WAS DETACHED AT PROXIMAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495348 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THE GUIDEWIRE WAS DIFFICULT TO REMOVE. A 7.3 FLEXIMA APDL WAS SELECTED FOR USE IN A LIVER ABSCESS DRAINAGE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE ABSCESS OVER A GUIDEWIRE. AN ATTEMPT WAS MADE TO REMOVE THE METAL STYLET, BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, ANOTHER ATTEMPT WAS MADE TO REMOVE THE DEVICE, LEAVING THE GUIDE WIRE, BUT WAS UNSUCCESSFUL, SO EVERYTHING WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360806 ↗