Flexima™ APDL M001271350Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729323112), received between Jan 2, 2019 and Jul 27, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Break; Deformation Due to Compressive Stress

  It was reported that cannula break and kink occurred, requiring an additional device. The non-stenosed target lesion was located in the mildly tortuous and mildly calcified vessel. A Flexima APDL Drainage Catheter was selected for use. The drainage catheter was placed without any issues noted during package opening, device preparation, or at the time of patient discharge. However, the patient returned three days after the procedure with a broken drain. The break was observed near the luer lock hub, at the interface where the drainage catheter meets the white component attached to the hub. The device was removed intact, and the catheter was replaced during an additional procedure. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038381 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THE DEVICE MATERIAL BROKE AND AN UNRETRIEVED DEVICE FRAGMENT CAUSED A MINOR INJURY TO THE PATIENT. DURING FLEXIMA? APDL DEVICE, PART OF THE LOCKING LOOP SUTURE BROKE AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN CUT THE FLEXIMA? APDL DEVIC JUST BELOW THE HUB AND PROCEEDED TO PULL THE DEVICE OUT WITHOUT FIRST INSERTING A WIRE TO STRAIGHTEN THE DRAIN. AS THE DEVICE WAS REMOVED, THE SUTURE IN THE LOCKING LOOP BROKE, RESULTING IN A DEVICE FRAGMENT BEING LEFT BEHIND IN THE PATIENT. ALTHOUGH THE EVENT WAS INITIALLY DESCRIBED AS ONGOING, ADDITIONAL INFORMATION RECEIVED THROUGH THE GOOD FAITH EFFORT (GFE) PROCESS STATES THE PATIENT IS DOING WELL WITH NO COMPLICATIONS. A CARDIOTHORACIC SURGEON EVALUATED THE RETAINED SUTURE FRAGMENT AND DETERMINED THAT SURGICAL REMOVAL WOULD POSE A HIGHER RISK THAN LEAVING THE FRAGMENT INSIDE OF THE PATIENT. THE PATIENT HAS BEEN CHECKED TWICE SINCE THE EVENT AND CONTINUES TO DO WELL WITHOUT ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24136777 ↗
• InjuryJul 10, 2024Break; Break

  IT WAS REPORTED THAT SURGICAL INTERVENTION WAS ATTEMPTED TO REMOVE A BROKEN DRAINAGE CATHETER TIP. ON (B)(6) 2024, AN ALL-PURPOSE DRAINAGE CATHETER WAS PLACED INTO THE GALLBLADDER TO DRAIN AN INFECTION AND BILE. ON (B)(6) 2024, THE PATIENT WAS INTUBATED FOR RESPIRATORY FAILURE, EXHAUSTION, SEPSIS, AND MULTI-ORGAN FAILURE. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED INCREASING SIZE OF PERIHEPATIC COLLECTION. A DRAINAGE CATHETER WAS PLACED INTO THE PERIHEPATIC COLLECTION. THERE WERE TWO DRAINAGE CATHETERS IN USE AT THIS POINT. A PERCUTANEOUS DRAINAGE CATHETER INTO THE COLLAPSED GALLBLADDER, AND A PERCUTANEOUS DRAINAGE CATHETER IN PERIHEPATIC COLLECTION. ON (B)(6) 2024, THE DRAINAGE CATHETERS WERE BOTH REMOVED, AND TWO NEW DRAINAGE CATHETERS WERE PLACED. ON (B)(6) 2024, A CT SCAN NOTED THAT A DRAINAGE CATHETER APPEARED TO HAVE BEEN CUT/SNAPPED AND LIES IN THE ABDOMINAL WALL APPROXIMATELY 2CM BELOW THE LEVEL OF THE SKIN. ON (B)(6) 2024, THE PATIENT WAS DETERIORATING, REPEAT ABDOMINAL CT SCANS REVEALED THE RETAINED DRAIN, THE PERIHEPATIC COLLECTION REMAINS ESSENTIALLY STABLE. ON (B)(6) 2024, ULTRASOUND OF THE ABDOMINAL WALL WAS PERFORMED, AND THE TIP OF THE DRAIN WAS SEEN IN THE ABDOMINAL WA

  Patient problems: Foreign Body In Patient

  MAUDE report 19715955 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT SUTURE DETACHMENT OCCURRED AND THERE WAS DIFFICULTY REMOVING THE DRAINAGE CATHETER WHICH RESULTED IN PAIN WITHOUT INTERVENTION. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE IN THE CHEST. DURING REMOVAL, THE TUBE WAS PULLED, HOWEVER, THE STRING RETAINED WITH TWO ENDS COMING OUT OF WOUND. THE STRING WAS PULLED USING A LOT OF FORCE. THE PROCEDURE WAS PAINFUL AND TOOK LONGER. THE SUTURE WAS COMPLETELY REMOVED FROM THE PATIENT BY A SURGEON. NO APPARENT HARM WAS NOTED WITH THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 18607373 ↗
• MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER HUB CAME OFF. A 10 FLEXIMA APDL WAS PLACED ON (B)(6) 2019 AND ON (B)(6) 2019 THE HUB ON THE FLEXIMA DRAINAGE CATHETER DETACHED. THE DRAINAGE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE FLEXIMA WAS NOT PLACED IN THE CHEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157580 ↗
• MalfunctionJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUN2019. A FLEXIMA APDL CATHETER DRAINAGE DEVICE WAS RECEIVED WITH MFR REPORT# 10877315 WITH NO REPORTED ISSUES. HOWEVER, DEVICE ANALYSIS OBSERVED CATHETER SEPARATED/CUT AT THE PROXIMAL SECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8772067 ↗
• MalfunctionJul 9, 2019Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUN2019. IT WAS REPORTED THAT THE DRAINAGE BAG CANNOT BE SECURED. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DRAIN WOULD NOT SECURE TO THE DRAINAGE BAGS AND WAS THEN PULLED UP. THE PROCEDURE WAS NOT COMPLETED DUE TO THE ISSUE AND THE PATIENT WENT BACK IN FOR DIFFERENT PROCEDURE AND PLACE DIFFERENT DRAINS. NO COMPLICATIONS REPORTED AND PATIENT IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED CATHETER SEPARATED/CUT AT THE PROXIMAL SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771936 ↗
• MalfunctionMay 28, 2019Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE COMMON BILE DUCT. A FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, THE SUTURE NOTED TO BE BROKEN AND THE DEVICE WAS THEN SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646163 ↗
• InjuryJan 2, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SERIOUS INJURY. THE PIGTAIL OF THE FLEXIMA APDL REMAINED LOCKED EVEN IN AN UNLOCKED POSITION. CONSEQUENTLY, A SERIOUS INJURY OCCURRED DUE TO THE DIFFICULTY IN REMOVING THE PIGTAIL DRAIN. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8209625 ↗