Flex-Neck® 00884450330241Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450330241), received between Jul 17, 2020 and Sep 27, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT, POST PROCEDURE, A PATIENT WAS BEING TREATED FOR A TUNNEL INFECTION AND EMPIRICALLY FOR PERITONITIS. A CVC WAS PLACED FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Peritonitis

  MAUDE report 20321802 ↗
• InjurySep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER ALLEGES THEY ARE HAVING ISSUES GETTING A CATHETER TO WORK. WHEN TRYING TO FLUSH WITH A SYRINGE, THEY REALIZED THAT THE FLUID SEEMED TO BE GOING INTO THE PATIENT'S TUNNEL, CREATING A BUBBLE BETWEEN INCISIONS IN THE CATHETER TUNNEL. THE PATIENT WAS STARTED ON ANTIBIOTICS FOR THE TUNNEL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20300532 ↗
• MalfunctionSep 11, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERITONEAL DIALYSIS CATHETER PLACEMENT PROCEDURE, A PLASTIC CONNECTION DETACHED WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY REMOVED THE DEVICE LAPAROSCOPICALLY WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE DIALYSIS CATHETER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10521322 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A PATIENT HAD A PERITONEAL DIALYSIS CATHETER PLACED. THE CATHETER WAS NOT WORKING SO THE PATIENT RETURNED TO THE HOSPITAL. THE PATIENT WAS ADMITTED FOR A LAPAROSCOPIC SCOPE PROCEDURE. THE PHYSICIAN FOUND THAT CATHETER HAD ADHERED TO THE PERITONEAL WALL OF THE PATIENT. THE PHYSICIAN ALSO NOTED THAT A CATHETER GUIDE ASSEMBLY WAS LEFT WITHIN THE PATIENT FROM THE LAST IMPLANT PROCEDURE. THE ASSEMBLY WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN COMPLETED SOME MINOR MAINTENANCE ON THE CATHETER. THE PD CATHETER WAS LEFT WITHIN THE PATIENT FOR CONTINUED USE. THE PHYSICIAN STATED THAT THERE WERE NO SIGNS OF INFECTION. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10289910 ↗