Flex-Neck® 00884450330166Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450330166), received between Jun 10, 2020 and Aug 20, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES DURING THE CATHETER PLACEMENT PROCEDURE, THE CATHETER BROKE WHILE BEING PULLED THROUGH THE SUBCUTANEOUS TUNNEL. AS A RESULT, THE CATHETER WAS COMPLETELY REMOVED FROM THE PERITONEAL CAVITY. A REPLACEMENT PERITONEAL CATHETER OF THE SAME REFERENCE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853847 ↗
• InjuryAug 5, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE CATHETER WAS PLACED INTO THE PELVIS, AND WHEN THE CLINICIAN ATTEMPTED TO TUNNEL IT USING A METAL TUNNELER, WHILE EXITING THE SKIN THE CATHETER BROKE AND SEPARATED AT THE SECOND CUFF. THE CLINICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE OF THE CATHETER. A REPLACEMENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717355 ↗
• InjurySep 19, 2024Obstruction of Flow; Defective Device; Migration; Obstruction of Flow; Defective Device; Migration

  THE ACCOUNT ALLEGES THAT AN 82-YEAR-OLD MALE PATIENT PRESENTED IN A WHEELCHAIR CONSCIOUS AND ORIENTED. THE FUNCTIONALITY OF THE CATHETER WAS EVALUATED. AN ABDOMINAL X-RAY WAS PERFORMED SHOWING THE CATHETER HAD MIGRATED OUTSIDE THE PELVIC CAVITY. OUT OF POSITION. THE DRAINAGE CATHETER WAS TESTED, AND IT WAS FOUND THAT THE PD CATHETER WAS OCCLUDED AND WOULD NOT DRAIN. THE PHYSICIAN ORDERED THE PD CATHETER REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261108 ↗
• MalfunctionDec 20, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE ACCOUNT ALLEGES THAT A PERITONEAL DIALYSIS PROCEDURE THE PHYSICIAN WAS ABLE TO PLACE THE CATHETER WITHOUT TROUBLE. ONCE THE PHYSICIAN WENT TO FLUSH THE CATHETER HE NOTICED IT WAS LEAKING. THE PHYSICIAN PLACED A PURSE STRING SUTURE AND TRIED AGAIN AND THE CATHETER CONTINUED TO LEAK. PHYSICIAN DECIDED TO REMOVE THE CATHETER AND PLACE ANOTHER CATHETER. ONCE THE PHYSICIAN REMOVED THE INITIAL CATHETER HE ATTEMPTED TO FLUSH IT AND THE CATHETER HAD A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016300 ↗
• MalfunctionJun 10, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE ACCOUNT ALLEGES DURING A PROCEDURE, WHILE TUNNELING THE CATHETER TO THE EXIT SITE, THE CATHETER BROKE AT THE FIRST CUFF. THE CUFF WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10141381 ↗