Flex-Neck® 00884450170298Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450170298), received between Dec 5, 2017 and Dec 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2017Inadequacy of Device Shape and/or Size; Incomplete or Missing Packaging; Packaging Problem

  (B)(6) INFANT WITH A HISTORY OF END-STAGE RENAL DISEASE. HE HAS UNDERGONE HEMODIALYSIS AND HIS PRIMARY NEPHROLOGIST REQUESTED A PERITONEAL DIALYSIS CATHETER TO BE INSERTED FOR LONG-TERM RENAL REPLACEMENT THERAPY. WHEN THE PERITONEAL DIALYSIS CATHETER 2 CUFFS PEDIATRIC COILED PACKAGE WAS OPENED IN PREPARATION FOR INSERTION, IT WAS DISCOVERED THE PACKAGE DID NOT CONTAIN THE RIGHT PERITONEAL CATHETER. SEVERAL OTHER PACKAGES OPENED WITH SAME RESULTS. THE DISTAL CUFF TO COIL LENGTH WAS LONGER THAN WHAT WAS INDICATED ON THE PACKAGING. SURGEON HAD TO PLACE AN INFANT SIZED CATHETER. PER SURGEON, THE CATHETER ENCLOSED IN THE PACKAGE WAS TOO BIG FOR THE PATIENT, AND THE MEASUREMENTS INDICATED ON THE PACKAGING DID NOT MATCH THE CATHETER ENCLOSED. ALL PERITONEAL CATHETERS OF ALL SIZES (INFANT, PEDIATRIC, ADOLESCENT, ADULT SMALL AND ADULT REGULAR) PULLED FROM STOCK. THERE IS A CONCERN THIS INFANT CATHETER MAY NOT WORK PROPERLY FOR THE PATIENT AS IT HAD BEEN REQUESTED TO TRY TO AVOID THE NEONATAL SIZE BECAUSE OF SMALLER DIAMETER TO ALLOW FOR BETTER LUMEN. THE PD CATHETER THE PATIENT PREVIOUSLY HAD BEFORE HEMODIALYSIS WAS NEONATAL AND PER NEPHROLOGIST WAS A STRUGGLE BECAUSE OF THE LUMEN. PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082126 ↗