Flexima™ APDL M001271380Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729323143), received between Dec 12, 2018 and Dec 22, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2025. A FLEXIMA ALL PURPOSE DRAINAGE WAS RETURNED TO THE QUALITY ASSURANCE WITH NO REPORTED ALLEGATION. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865374 ↗
• MalfunctionOct 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290201 ↗
• MalfunctionSep 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SUTURE BREAK OCCURRED. A 12F FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. POST CATHETER PLACEMENT, IT WAS NOTED THE CATHETER WAS BREAKING AT THE HUB AND SUTURE AREA. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND IT WAS EXCHANGED WITH A NEW DRAINAGE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183622 ↗
• MalfunctionSep 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SUTURE BREAK OCCURRED. A 12F FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. POST CATHETER PLACEMENT, IT WAS NOTED THE CATHETER WAS BREAKING AT THE HUB AND SUTURE AREA. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND IT WAS EXCHANGED WITH A NEW DRAINAGE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183621 ↗
• InjurySep 22, 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, WITHIN ONE WEEK IT WAS OBSERVED THAT THE DRAINAGE CATHETER BROKE AT THE HUB WHICH RESULTED IN PAIN. THE PATIENT WAS REQUIRED TO RETURN TO THE HOSPITAL FOR DEVICE REMOVAL AND REPLACEMENT WITH A NEW DRAINAGE CATHETER. IT WAS FURTHER REPORTED THAT NO PAIN AND DISCOMFORT WAS FELT BY THE PATIENT, AND THE DEVICE WAS EXCHANGED FOR A NEW DRAIN. IT WAS NOTED THAT THERE WAS NO DIFFICULTY CHANGING THE DRAINAGE CATHETER BECAUSE THEY WOULD USUALLY BE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23110947 ↗
• MalfunctionAug 15, 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

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 22JUL2025. IT WAS REPORTED THAT FLEXIMA DRAIN SEPARATED FROM THE HUB WHEN REMOVING. A FLEXIMA? ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FLEXIMA DRAIN DISCONNECTED FROM THE HUB WHILE BEING REMOVED FROM THE PATIENT AND WAS SUBSEQUENTLY RETRIEVED IN TWO SEPARATE PIECES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SUTURE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816654 ↗
• MalfunctionJan 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS HAIR INSIDE THE SEALED PACKAGE. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE. DURING SHIPMENT, IT WAS NOTED THAT THERE WAS HAIR INSIDE THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258598 ↗
• MalfunctionFeb 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER HUB DETACHED. A FLEXIMA APDL WAS SELECTED FOR USE IN THE CHEST. DURING ONGOING USE, IT WAS NOTED THAT THE DEVICE CAME APART AT THE HUB. THE DEVICE WAS REMOVED USING THE NORMAL PROCEDURE PROTOCOL. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9676734 ↗
• MalfunctionOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12SEP2019. A FLEXIMA APDL CATHETER DRAINAGE WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, ANALYSIS REVEALED HUB DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9152291 ↗
• MalfunctionJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB CAME APART. A 12FR FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE CAME APART AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784772 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB DETACHED. A 12 FLEXIMA APDL CATHETER DRAINAGE WAS USED. IT WAS NOTED THAT THE HUB DETACHED AS THE WHITE CUFF PULLED AWAY FROM THE BLUE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748499 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB DETACHED. A 12 FLEXIMA APDL CATHETER DRAINAGE WAS USED. IT WAS NOTED THAT THE HUB DETACHED AS THE WHITE CUFF PULLED AWAY FROM THE BLUE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748487 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB DETACHED. A 12 FLEXIMA APDL CATHETER DRAINAGE WAS USED IN A RIGHT CHEST TUBE PLACEMENT. IT WAS NOTED THAT THE HUB DETACHED AS THE WHITE CUFF PULLED AWAY FROM THE BLUE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748486 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB DETACHED. A 12 FLEXIMA APDL CATHETER DRAINAGE WAS USED. IT WAS NOTED THAT THE HUB DETACHED AS THE WHITE CUFF PULLED AWAY FROM THE BLUE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748483 ↗
• MalfunctionJun 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE DETACHED NEAR THE HUB. A 12 FLEXIMA APDL DRAINAGE CATHETER WAS USED IN A CHEST TUBE IN THE RIGHT PLEURAL SPACE FOR EFFUSION. HOWEVER, IT WAS NOTED THAT THE DEVICE CAME APART NEAR THE HUB. THE DEVICE WAS THEN REMOVED AND A NEW DEVICE WAS IMPLANTED INTO THE PATIENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. THE PATIENT WILL LIKELY TO RETURN WITHIN THE NEXT 1-2 WEEKS TIME FOR SUBSEQUENT TUBE REMOVALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722093 ↗
• MalfunctionJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER CAME APART. A FLEXIMA APDL WAS INSERTED FOR DRAINAGE. APPROXIMATELY THREE WEEKS LATER, THE BOND AREA BETWEEN THE FLEXIMA MATERIAL AND THE WHITE PLASTIC SLEEVE CAME APART. THE FLEXIMA WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666978 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT THE DEVICE THAT WAS LOCATED IN THE CHEST BROKE NEAR THE VALVE VIA MEDWATCH MW5081074. A FLEXIMA APDL WAS USED IN A PROCEDURE IN THE RIGHT SIDED CHEST TUBE. THE TUBE SEPARATED NEAR THE VALVE. THE FIRST TIME IT OCCURRED WAS ON DAY TWO OF USAGE (OCT 20) AND THE DEVICE WAS NOT COMPROMISED AS IT WAS ABLE TO BE PUT BACK TOGETHER. ON OCT 22, IT HAD TO BE REMOVED DUE TO AN INABILITY TO KEEP THE DEVICE INTACT. THE ISSUE WAS REPORTED AS SERIOUS AS THE DEVICE HAD TO BE REPLACED. ANOTHER PROCEDURE WAS REQUIRED TO RE-INSTATE THE THERAPY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8157477 ↗