Flexima™ APD™ M001271360Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729323129), received between Mar 18, 2021 and Oct 16, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HUB SEPARATED WHICH REQUIRED AN ADDITIONAL DEVICE. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE. THE DEVICE WAS SUCCESSFULLY PLACED IN THE PATIENT, AND THE PATIENT WAS DISCHARGED HOME. HOWEVER, THE HUB SEPARATED AND THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR A DEVICE REPLACEMENT. THE DRAINAGE CATHETER WAS SUCCESSFULLY REMOVED, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. IT WAS FURTHER REPORTED THAT THE TUBE APPEARED TO BE BROKEN AND WAS REMOVED FROM THE PATIENT INTACT. THE FRACTURE WAS OBSERVED AT THE JUNCTION WHERE THE BLUE SECTION OF THE FLEXIMA DRAIN MEETS WITH THE WHITE SECTION. THE DRAINAGE CATHETER WAS PLACED LESS THAN 48 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316428 ↗
• InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN HUB OCCURRED THAT REQUIRED DEVICE REPLACEMENT. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE DRAIN FRACTURED AT THE HUB AFTER THE PATIENT WAS SENT HOME WHICH RESULTED IN UNDESIRED SENSATIONS. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER. IT WAS FURTHER REPORTED THAT THE TUBE WAS BROKEN APART, AND THE STRING WAS EXPOSED. THE FRACTURE WAS OBSERVED AT THE JUNCTION WHERE THE BLUE SECTION OF THE FLEXIMA DRAIN MEETS WITH THE WHITE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292673 ↗
• InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN HUB OCCURRED THAT REQUIRED DEVICE REPLACEMENT. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE DRAIN FRACTURED AT THE HUB AFTER THE PATIENT WAS SENT HOME. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT RETURNED TO THE HOSPITAL TO HAVE THE DEVICE EXCHANGED FOR A NEW ONE AS THE DEVICE HAD FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291874 ↗
• InjuryOct 15, 2025Fluid/Blood Leak; Leak/Splash; Detachment of Device or Device Component; Fluid/Blood Leak; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BROKEN HUB OCCURRED THAT REQUIRED DEVICE REPLACEMENT. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE DRAIN FRACTURED AT THE HUB AFTER THE PATIENT WAS SENT HOME WHICH RESULTED IN UNDESIRED SENSATIONS. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER. IT WAS FURTHER REPORTED THE TUBE WAS BROKEN AND LEAKING AND ALL PARTS WERE REMOVED FROM THE PATIENT. THE FRACTURE WAS LOCATED AT THE JUNCTION WHERE THE BLUE SECTION OF THE FLEXIMA DRAIN MEETS WITH THE WHITE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291801 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE THREAD WAS PULLED DOWN IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE BILIARY ARTERY. A 12 FLEXIMA APD WAS SELECTED FOR USE. DURING REMOVAL OF THE DEVICE, THE THREAD WAS PULLED DOWN DEEP IN THE CATHETER. THE PHYSICIAN HAD TO GRAB THE CATHETER TO REMOVE THE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330010 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE THREAD WAS CUT. A 12 FLEXIMA APD WAS SELECTED FOR USE. DURING DEVICE REMOVAL, THE THREAD WAS CUT INTO TWO; THE PHYSICIAN WAS ABLE TO PULL OUT THE THREAD SEPARATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN VERY GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329165 ↗
• MalfunctionFeb 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. AN APD/12 FLEXIMA REGULAR ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR BILIARY DRAINAGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER'S THREAD WAS STUCK IN THE VESSEL UPON 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 16326952 ↗
• InjuryMar 18, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH (B)(4) THAT THE TUBE WAS DISLODGED AND SEPARATED. A FLEXIMA APD WAS SELECTED FOR USE AND PLACED AS A CHEST TUBE. HOWEVER, IT WAS NOTED THAT THE CHEST TUBE WAS DISCONNECTED AND WAS CLAMPED. X-RAY WAS IMMEDIATELY DONE AND SHOWED THAT THE TUBE WAS DISLODGED. THE CHEST TUBE WAS REMOVED IN INTERVENTIONAL RADIOLOGY LATER SAME DAY. THE TUBE WAS EXAMINED, AND IT WAS PULLED APART FROM WHERE IT WAS ATTACHED TO THE HUB, AND WAS SEPARATED AT THE CONNECTION OF THE DISTAL LOWER LUMBAR BACK. THE GLUE HOLDING THE TUBING ON THE HUB DID NOT HOLD. ADDITIONAL INTERVENTION WAS REQUIRED, AND THE DEVICE WAS SUCCESSFULLY REMOVED OVER A WIRE UNDER FLUOROSCOPY. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST DEVICE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515844 ↗