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Xcela 25129Recalls & reported problems

Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 6F x 55cm Triple Lumen Catheter MST-70 Kit · Class 2 · Implant

All models of Xcela (39)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 H965251290), received between Oct 12, 2016 and Oct 12, 2016 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Fluid Discharge1

Recent adverse event reports

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

  • MalfunctionOct 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED, SEVERAL HOURS AFTER THE PICC WAS PLACED, LEAKAGE WAS NOTED AT THE INSERTION SITE FOLLOWING A FLUSH. THE PICC WAS REMOVED AND REPLACED.

    Patient problems: Fluid Discharge

    MAUDE report 6024387 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources and updates

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