Flexima™ APDL M001275030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729300694), received between Dec 14, 2023 and Feb 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 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.

• MalfunctionFeb 6, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE STENT BROKE. ON (B)(6) 2025, A 7.3 FLEXIMA ALL-PURPOSE DRAINAGE CATHETER WAS SELECTED FOR PERCUTANEOUS LIVER ABSCESS DRAINAGE. HOWEVER, THE FOLLOWING DAY, IT WAS NOTED THROUGH THE COMPUTERIZED TOMOGRAPHY (CT) THAT THE TUBE HAD COME OFF WITHIN THE LIVER. SUBSEQUENTLY, ON (B)(6) 2025, THE TUBE STENT WAS REMOVED. THE PIGTAIL WAS NOT STRAIGHTENED, SO THE TUBE WAS REMOVED WHILE STRAIGHTENING IT WITH A GUIDEWIRE. THE SUTURE SEEMED TO GET CAUGHT ON SOMETHING AND COULD NOT BE PULLED OUT, SO THE PROCEDURE WAS UNAVOIDABLY COMPLETED WITH A REMAINING SUTURE INSIDE THE BODY, APPROXIMATELY 2CM FROM THE BODY SURFACE. ON (B)(6) 2025, THE SUTURE WAS COMPLETELY PULLED INSIDE THE PATIENT WHEN VISUALLY CHECKED. AT THIS TIME, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. AS PER PHYSICIAN, IT IS POSSIBLE THAT A STRUCTURE WAS FORMED WITHIN THE LIVER AND THE SUTURE MAY HAVE BEEN CAUGHT THERE. HOWEVER, THE PHYSICIAN DOUBTED THAT A STRUCTURE COULD BE FORMED SO QUICKLY BECAUSE IT HAS NOT BEEN LONG SINCE IT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21323295 ↗
• InjuryDec 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE WAS IMPLANTED. A 7.3 FR FLEXIMA ALL PURPOSE DRAINAGE CATHETER WITH LOCK WAS SELECTED FOR USE. DURING DEVICE REMOVAL, A RESISTANCE WAS FELT WHEN THE REMAINING SUTURE WAS RETRIEVED. THERE WAS A CONCERN THAT THIS WOULD DAMAGE THE ORGANS BY PULLING OUT THE DEVICE BY FORCE. THE SUTURE WAS CUT OUT AND THE REMAINING PART WAS IMPLANTED SUBCUTANEOUSLY. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18372698 ↗
• InjuryDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BROKEN SUTURE REMAINED IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE NOT TIGHTLY TORTUOUS BILE DUCT. A 7.3 FLEXIMA APDL ALL PURPOSE DRAINAGE WAS SELECTED FOR IMPLANT. DURING REMOVAL, FIRST CATHETER WAS CUT AND PULLED OUT. HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE SUTURE WAS PULLED OUT AND IT GOT SEPARATED, AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE; HOWEVER, AN ADVERSE HEALTH EFFECTS WAS CONFIRMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18330795 ↗