Flexima™ APDL M001271340Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729323105), received between Nov 19, 2019 and Sep 2, 2026 — classified as 2 deaths, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Deformation Due to Compressive Stress

  Patient problems: Abdominal Pain; Diaphoresis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50570609 ↗
• MalfunctionDec 12, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14NOV2025. IT WAS REPORTED THAT CATHETER WAS BLOCKED. A FLEXIMA APDL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BLOCKED AND THE LIQUID COULD NOT BE DRAWN OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE TIP OF THE TROCAR PERFORATED THE STENT, AND PART OF THE TIP IS VISIBLE THROUGH THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790542 ↗
• InjuryAug 22, 2025Material Separation; Defective Device; Material Separation; Defective Device

  IT WAS REPORTED THAT A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT, AND ADDITIONAL INTERVENTION WAS REQUIRED. A FLEXIMA? APDL WAS SELECTED FOR USE. THE PATIENT ATTENDED A HOSPITAL APPOINTMENT AS PLANNED FOR DRAIN REVIEW. DRAIN OUTPUT WAS BELOW THRESHOLD, SO IT WAS DETERMINED THAT THE DRAIN COULD BE REMOVED. THE DRAIN APPEARED UNREMARKABLE, BUT WAS CHALLENGING TO REMOVE. DESPITE DISENGAGING THE PIGTAIL, THERE WAS RESISTANCE. THEREFORE, THE DECISION WAS MADE TO CUT THE DRAIN AND WITHDRAW, WHICH WAS AN ACCEPTED PRACTICE IN INTERVENTIONAL RADIOLOGY (IR). THIS ALLOWED THE DRAIN TO BE EASILY REMOVED. HOWEVER, THE DRAIN STRING REMAINED TETHERED. THE STRING WAS CUT AWAY FROM THE DRAIN, BUT IT COULD NOT BE REMOVED. A SPECIALIST WAS BROUGHT IN WHO ATTEMPTED TO REMOVE THE STRING BUT COULD NOT. DESPITE EFFORTS IN THE IR LAB WITH INTRODUCERS, THE STRING WAS UNABLE TO BE REMOVED. THEREFORE, THE STRING WAS CUT SHORT BY AN IR FELLOW AND LEFT WITHIN THE PATIENT'S ABDOMINAL WALL. THE DEVICE APPEARED TO HAVE BEEN INSERTED, DISENGAGED, AND REMOVED APPROPRIATELY. IT WAS FURTHER REPORTED THAT THE DRAIN WAS IMPLANTED FOR SUB-CUTANEOUS ABDOMINAL COLLECTION FOLLOWING AN ABDOMINAL SURGERY. THE DRAIN HAD B

  Patient problems: Foreign Body In Patient

  MAUDE report 22873561 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT THE SUTURE PIGTAIL BROKE. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR RIGHT PERCUTANEOUS NEPHROSOMY (PCN) CATHETER EXCHANGE. DURING THE PROCEDURE, WHEN THE DRAIN WAS ABOUT TO PLACED, IT WAS NOTED THAT THE SUTURE PIGTAIL BROKE BEFORE IT COULD BE LOCKED INTO PLACE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660127 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE STIFFENING CANNULA APPEARS TO HAVE PUNCTURED THE DRAIN. DURING PREPARATION, THE FLEXIMA APDL STIFFENING CANNULA APPEARS TO HAVE PUNCTURED THE DRAIN IN THE PACKAGE. NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATION REVEALED THAT THE CATHETER PIG TAIL SECTION WAS TORN WITH THE TROCAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478537 ↗
• MalfunctionNov 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK DURING REMOVAL. AN APDL/8 FLEXIMA REGULAR WAS SELECTED FOR ULTRASOUND-GUIDED PERCUTANEOUS TRANSHEPATIC CHOLECYSTECTOMY. DURING THE PROCEDURE, A 18GPTC PUNCTURE NEEDLE CROSSED THE LOWER PART OF THE GALLBLADDER, AND THE NEEDLE CORE WAS PULLED OUT. A SMALL AMOUNT OF GREEN BILE WAS FOUND TO FLOW OUT, AND A GUIDEWIRE WAS INSERTED, THE PUNCTURE NEEDLE WITHDRAWN. THE SKIN WAS EXPANDED WITH AN 8F EXPANDER, AND AN 8F DRAINAGE CATHETER WAS SENT INTO THE GALLBLADDER ALONG THE GUIDEWIRE, THE GUIDEWIRE WITHDRAWN. HOWEVER, DRAINAGE WITH THE 8F CATHERTER WAS NOT SMOOTH, SO IT WAS PULLED OUT, DURING WHICH THE FIXED WIRE WAS ENTANGLED IN THE TISSUE AND COULD NOT BE PULLED OUT. THUS, THE FIXED WIRE WAS CUT AND THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074369 ↗
• InjuryDec 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE STRING SNAPPED AND REMAINED IN THE PATIENT. AN 8/APDL FLEXIMA REGULAR DRAINAGE CATHETER HAD BEEN IMPLANTED ON A PRIOR DATE. DURING REMOVAL OF THE FLEXIMA, THE DRAINAGE CATHETER WAS REMOVED EASILY. THE PREVIOUSLY IMPLANTED FLEXIMA DRAINAGE CATHETER WAS EASILY REMOVED. HOWEVER, WHILE ATTEMPTING TO REMOVE THE STRING, THERE WAS SIGNIFICANT RESISTANCE. IT WAS THOUGHT THAT THE SUTURE HAD BECOME EMBODIED WITH FIBROUS TISSUE. A SIGNIFICANT LENGTH OF THE STRING WAS REMOVED DESPITE THE DIFFICULT BUT THEN SNAPPED UNDER TENSION. THE RESIDUAL LENGTH OF THE STING WAS LEFT WITHIN THE RENAL AND PERIRENAL TISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15983135 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE. AN 8FR FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE IN A NEPHROSTOMY PROCEDURE. DURING THE PROCEDURE, THE SUTURE WHICH HOLD THE DRAINAGE CATHETER IN PLACE, BROKE. THE CATHETER WAS EXCHANGE FOR A NEW DEVICE OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15952454 ↗
• MalfunctionNov 8, 2021Break; Difficult to Remove; Break; Difficult to Remove

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON 03NOV2021. IT WAS REPORTED THAT THE DEVICE STUCK INSIDE THE PATIENT AND BROKE WHEN PULLED OUT. TWO FLEXIMA APDL WERE SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED IN REMOVING THE DEVICES AS IT GOT STUCK INSIDE THE PATIENT. SUBSEQUENTLY, THE DEVICES WERE REMOVED BY PULLING IT WITH A STRONG FORCE WHICH WAS HARD ENOUGH THAT IT BROKE APART AND THE PLASTIC STIFFENER CAME APART INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12773601 ↗
• MalfunctionNov 8, 2021Break; Difficult to Remove; Break; Difficult to Remove

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON 03NOV2021. IT WAS REPORTED THAT THE DEVICE STUCK INSIDE THE PATIENT AND BROKE WHEN PULLED OUT. TWO FLEXIMA APDL WERE SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED IN REMOVING THE DEVICES AS IT GOT STUCK INSIDE THE PATIENT. SUBSEQUENTLY, THE DEVICES WERE REMOVED BY PULLING IT WITH A STRONG FORCE WHICH WAS HARD ENOUGH THAT IT BROKE APART AND THE PLASTIC STIFFENER CAME APART INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12773598 ↗
• InjuryApr 8, 2021Break; Break

  IT WAS REPORTED THAT CATHETER WAS FRACTURED AND HAD TO BE SNARED. A FLEXIMA APDL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE PIGTAIL BECAME FRACTURED AND HAD TO BE SNARED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637938 ↗
• MalfunctionJul 22, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING SEAL WAS COMPROMISED. AN 8FR FLEXIMA APDL DRAINAGE CATHETER WAS RECEIVED WITH THE PACKAGE OPENED ALONG ITS LENGTH. THE DEVICE WAS NOT USEABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10309609 ↗
• DeathJun 17, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. TWO FLEXIMA APDL CATHETERS WERE SELECTED FOR DRAINAGE PLACEMENT ON (B)(6) 2020. BOTH CATHETERS HAD BLOCKAGE 24 DAYS POST IMPLANTATION AND COULD NOT FUNCTION APPROPRIATELY. THE ISSUE WAS NOT RESOLVED AND THE PATIENT DIED ON (B)(6) 2020.

  Patient problems: Death

  MAUDE report 10163692 ↗
• DeathJun 17, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. TWO FLEXIMA APDL CATHETERS WERE SELECTED FOR DRAINAGE PLACEMENT ON (B)(6) 2020. BOTH CATHETERS HAD BLOCKAGE 24 DAYS POST IMPLANTATION AND COULD NOT FUNCTION APPROPRIATELY. THE ISSUE WAS NOT RESOLVED AND THE PATIENT DIED ON (B)(6) 2020.

  Patient problems: Death

  MAUDE report 10163686 ↗
• MalfunctionMay 5, 2020Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE. THE TARGET LESION WAS LOCATED IN THE ASCITES. A FLEXIMA APDL WAS SELECTED FOR USE. DURING PROCEDURE, WHEN PULLING THE THREAD TO FORM A CATHETER DISTAL PIGTAIL OUTSIDE THE PATIENT'S BODY, IT WAS NOTED THAT THE THREAD WAS CUT AND ALL PORTIONS OF THE THREAD BECAME DETACHED FROM THE PATIENT. THE THREAD WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO ADDITIONAL INTERVENTION WAS NECESSARY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025245 ↗
• MalfunctionNov 19, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE SIZE WAS NOT WHAT WAS INDICATED ON THE PACKAGE. AN ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PIGTAIL WAS NOT THE SIZE THE PACKAGE INDICATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 9344071 ↗