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Flex-Neck® 00884450375006Recalls & reported problems

Merit Medical Systems, Inc. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450375006), received between Oct 27, 2020 and Oct 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 27, 2020Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT DURING A PERITONEAL DIALYSIS CATHETER PLACEMENT PROCEDURE ON AN INFANT, THE PERITONEAL DIALYSIS CATHETER BROKE WHILE PREPPING THE DEVICE FOR DEPLOYMENT. ANOTHER PD CATHETER WAS SUCCESSFULLY PREPPED AND PLACED WITHIN THE PATIENT. NO PATIENT INJURY TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10742916 ↗

Other Catheter, peritoneal, long-term indwelling devices

All Catheter, peritoneal, long-term indwelling devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.