Flexima™ APDL M001271330Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729323099), received between Sep 14, 2020 and Apr 15, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05APR2022. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS RETURNED FOR ANALYSIS WITH NO REPORTED COMPLAINT. HOWEVER, DEVICE ANALYSIS REVEALED THE STENT HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120354 ↗
• MalfunctionApr 15, 2022Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06APR2022. IT WAS REPORTED THAT THE TROCAR COULD NOT BE REMOVED FROM THE CATHETER. A FLEXIMA ALL PURPOSE DRAINAGE CATHETER WAS SELECTED FOR USE. THE TROCAR COULD NOT BE REMOVED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE STENT HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120346 ↗
• MalfunctionFeb 3, 2022Difficult to Remove; Defective Device; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Defective Device; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE REMOVAL DIFFICULTY OCCURRED. TWO APDL/6.3 FLEXIMA REGULAR ALL PURPOSE DRAINAGE WERE SELECTED FOR USE. THE FIRST DEVICE WAS ADVANCED OVER THE GUIDEWIRE AND THROUGH THE INCISION IN THE SKIN AND INSERTED IN THE PATIENT. DURING INSERTION, THE DEVICE STARTED TO CRUMPLE LIKE AN ACCORDION AND GOT STUCK. NO KINKS WERE NOTED. THE DEVICE WAS CAREFULLY REMOVED FROM PATIENT WITH INCREASED PULLING FORCE AND WAS A BIT PAINFUL. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED; HOWEVER, THE SAME ISSUE OCCURRED. AFTER CONFIRMING THE GUIDE WIRE WAS STILL IN THE RIGHT PLACE, AN APDL 8 FLEXIMA REGULAR CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 13446461 ↗
• MalfunctionFeb 3, 2022Difficult to Remove; Defective Device; Difficult to Advance; Difficult to Remove; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE REMOVAL DIFFICULTY OCCURRED. TWO APDL/6.3 FLEXIMA REGULAR ALL PURPOSE DRAINAGE WERE SELECTED FOR USE. THE FIRST DEVICE WAS ADVANCED OVER THE GUIDEWIRE AND THROUGH THE INCISION IN THE SKIN AND INSERTED IN THE PATIENT. DURING INSERTION, THE DEVICE STARTED TO CRUMPLE LIKE AN ACCORDION AND GOT STUCK. NO KINKS WERE NOTED. THE DEVICE WAS CAREFULLY REMOVED FROM PATIENT WITH INCREASED PULLING FORCE AND WAS A BIT PAINFUL. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED; HOWEVER, THE SAME ISSUE OCCURRED. AFTER CONFIRMING THE GUIDE WIRE WAS STILL IN THE RIGHT PLACE, AN APDL 8 FLEXIMA REGULAR CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 13446226 ↗
• InjuryNov 25, 2020Break; Break

  IT WAS REPORTED THAT THE DISTAL END OF THE DEVICE DETACHED. A 6.3 FLEXIMA APDL WAS USED FOR TREATMENT. UPON REMOVAL, THE DISTAL PIGTAIL END OF THE DRAINAGE CATHETER DETACHED AND REMAINED INSIDE THE PATIENT. ANOTHER PROCEDURE WAS PERFORMED TO SUCCESSFULLY REMOVE THE DETACHED PIGTAIL END. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906085 ↗
• InjurySep 14, 2020Break; Break

  IT WAS REPORTED THAT THE DRAINAGE CATHETER DETACHED AND REMAINED IN THE PATIENT. A 6.3 FLEXIMA APDL WAS SELECTED FOR A RENAL CYST PUNCTURE PROCEDURE UNDER LOCAL ANESTHESIA. DURING PROCEDURE, THE CATHETER WAS PLACED TO REACH THE RENAL CYST. THE DRAINAGE CATHETER WAS PUT IN PLACE ON THE GUIDE AND THE GUIDE WAS REMOVED. THE CYST WAS DRAINED WITH THE DRAINAGE CATHETER, THEN IT WAS INJECTED WITH CONTRAST PRODUCT AND IT WAS REMOVED BY THE DRAINAGE CATHETER, THEN INJECTED WITH 40CC ALCOHOL WITH A CONTACT TIME OF 15MIN. THEN, WHEN IT WAS NECESSARY TO REMOVE THE ALCOHOL ONLY 10CC WAS REMOVED, SO THE DRAINAGE CATHETER WAS MOVED IN ORDER TO RECOVER MORE ALCOHOL. THE PHYSICIAN NOTED A RUPTURE IN THE DRAINAGE CATHETER AND IT DETACHED INSIDE THE PATIENT. ONE PART OF THE DETACHED FRAGMENT REMAINED IN THE HANDS OF THE PHYSICIAN. AN ULTRASOUND SCAN PERFORMED THAT REVEALED A TWO FRAGMENT PIECES OF THE DRAINAGE CATHETER WERE INSIDE THE PATIENT. ONE PART OF THE DETACHED FRAGMENT REMAINED IN THE CYST AND ANOTHER PART WAS FOUND IN FRONT OF THE CYST AT THE PERIRENAL LEVEL. NO SURGERY WAS PERFORMED TO RETRIEVE THE TWO FRAGMENT PIECES OF THE DRAINAGE CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10528460 ↗