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Xcela 45676Recalls & reported problems

Navilyst Medical, Inc. · Xcela Power Injectable PICC - 4Fx55cm Catheter MST-60 Kit · 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 M001456760), received between Apr 19, 2016 and Apr 19, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 19, 2016Crack; Crack

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6): THE HUB OF THE PICC FELL OFF ONTO THE FLOOR WHILE THE PATIENT WAS AT HOME. PICC WAS REMOVED AND REPLACED. SALINE WAS BEING USED AS CATHETER LOCK SOLUTION BETWEEN TREATMENTS. NO PATIENT INJURY WAS REPORTED. THE USED DEVICE IS EXPECTED TO BE RETURNED TO ANGIODYNAMICS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5587101 ↗

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

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

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