Flexima™ APDL M001271960Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729323471), received between Dec 11, 2020 and Apr 29, 2025 — classified as 1 death, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE IN A BILE DUCT. DURING INSERTION, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930346 ↗
• MalfunctionOct 11, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A FLEXIMA APDL WAS SELECTED FOR USE IN A BILE DUCT. UPON OPENING THE OUTER BOX, THE PACKAGING OF THE DEVICE WAS DAMAGED AND LEAKING GAS, WHICH WAS NOT COMPLETELY SEALED. IT WAS SUSPECTED THAT THERE WERE BACTERIA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433500 ↗
• MalfunctionAug 21, 2024Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2024. IT WAS REPORTED THAT TIP KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT AND BILE DUCT LEAKAGE. TWO FLEXIMA ALL PURPOSE DRAINAGE CATHETERS WERE SELECTED FOR USE. HOWEVER, THE TIP OF BOTH DEVICES WAS KINK. A THIRD SET WAS USED AND SELECTED, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE DEVICE WAS CRUSHED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015412 ↗
• MalfunctionAug 21, 2024Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2024. IT WAS REPORTED THAT TIP KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT AND BILE DUCT LEAKAGE. TWO FLEXIMA ALL PURPOSE DRAINAGE CATHETERS WERE SELECTED FOR USE. HOWEVER, THE TIP OF BOTH DEVICES WAS KINK. A THIRD SET WAS USED AND SELECTED, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE DEVICE WAS CRUSHED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014854 ↗
• DeathAug 2, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT DIED. A FLEXIMA APDL CATHETER WAS SELECTED FOR USE IN AN EMERGENCY CASE, IN WHICH THE PATIENT WAS ALREADY IN BAD CONDITION. DURING THE PROCEDURE, AFTER THE PIGTAIL CATHETER WAS INSERTED INTO THE PATIENT, THE PHYSICIAN WANTED TO CONNECT THE CATHETER TO THE COLLECTION BAG, BUT THE LUER LOCK WAS LOOSE AND COULD NOT BE CONNECTED. A 30MM SYRINGE WAS USED INSTEAD TO COLLECT THE FLUID AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. TWO DAYS AFTER THE PROCEDURE DATE, THE PATIENT DIED WHILE THE CATHETER WAS STILL INSIDE THE PATIENT'S BODY. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE PRIMARY CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148833 ↗
• MalfunctionAug 31, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING FROM A HOLE. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE ON THE COMMON BILE DUCT. DURING THE PROCEDURE, WHEN FINAL ANGIOGRAPHY WAS PERFORMED, A LEAK WAS NOTED AT ABOUT 2/3 PART FROM THE DISTAL OF THE CATHETER. A SMALL HOLE WAS NOTED IN THE CATHETER WHERE THE LEAK OCCURRED. THE GUIDEWIRE WAS INSERTED AGAIN AND THE CATHETER WAS COMPLETELY REMOVED TOGETHER WITH THE GUIDEWIRE FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392830 ↗
• MalfunctionJul 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER TIP SPLIT. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE FOR A BILE DUCT BLOCKAGE. DURING UNPACKING, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS SPLIT AND CRACKED AND COULD NOT BE USED. THE DEVICE HAD NOT ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159752 ↗
• MalfunctionJul 8, 2021Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THE DRAINAGE CATHETER WAS FRACTURED. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE IN TREATING CANCER OF THE BILIARY DUCT. DURING UNPACKING, IT WAS NOTED THAT ONE PIECE OF THE BILIARY DUCT DRAINAGE CATHETER WAS FRACTURED. IT WAS ALSO NOTED THAT THE GUIDE WIRE WAS NOT SMOOTH AND THERE WERE BURRS ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139853 ↗
• MalfunctionJul 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE WIRE WAS FRACTURED. A FLEXIMA DRAINAGE CATHETER KIT WAS SELECTED FOR USE ON BILE DUCT BLOCKAGE. DURING THE PROCEDURE, AFTER THE DEVICE WAS DELIVERED, THE GUIDEWIRE WAS FRACTURED IN THE PATIENT. THE DEVICE WAS SIMPLY PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131499 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION AREA WAS LOCATED IN THE COMMON BILE DUCT ARTERY. A 8/K FLEXIMA APDL WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIO-DRAINAGE (PTCD) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED DURING EXTUBATION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993124 ↗