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Gastrostomy Feeding Tube with ENFit Connector 8884720163XRecalls & reported problems

Xeridiem Medical Devices, Inc. · Gastrostomy Feeding Tube with ENFit Connector 16FR · 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 00813939025064), received between Nov 24, 2021 and Nov 24, 2021 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

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.

  • MalfunctionNov 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE CONNECTOR CRACKED 48 HOURS AFTER SET UP IN THE PATIENT AND FORMULA LEAKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12869143 ↗

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