Flex-Neck® 00884450330159Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450330159), received between Mar 29, 2021 and Aug 18, 2022 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE ACCOUNT ALLEGES THAT AFTER IMPLANTING A PERITONEAL DIALYSIS CATHETER IN A PEDIATRIC PATIENT THEY EXPERIENCED ISSUES WITH LEAKING. MULTIPLE ATTEMPTS WERE MADE TO MINIMIZE THE LEAKING; HOWEVER, THEY WERE UNSUCCESSFUL. CONTRAST STUDY SHOWED EXCESSIVE LEAKING TWO WEEKS AFTER IMPLANT. THE CATHETER WAS REMOVED AND SHOWED THAT THE CATHETER HAD BROKEN INTO TWO HALVES AND SEPARATED JUST BELOW THE CUFF. THE PATIENT WAS TREATED FOR EXIT SITE INFECTION WITH ORAL ANTIBIOTICS AND A NEW DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254803 ↗
• InjuryMar 29, 2021Material Puncture/Hole; Material Puncture/Hole

  THE ACCOUNT ALLEGES THAT A PERITONEAL DIALYSIS CATHETER WAS IMPLANTED ON (B)(6) 2021, AND ON (B)(6) 2021 A SMALL HOLE WAS IDENTIFIED OUTSIDE THE CATHETER NEAR THE TRANSFER SET. THE CATHETER WAS TRIMMED TO REMOVE THE SMALL HOLE AND WAS THEN REINSERTED. ANTIBIOTICS WERE ADMINISTERED FOR 48 HOURS AS STANDARD PRECAUTIONS WARRANTED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584328 ↗