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Xcela 60M122272Recalls & reported problems

Navilyst Medical, Inc. · PICC Convenience 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 M00160M1222720), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

  • Material Rupture1

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.

  • MalfunctionMar 26, 2019Material Rupture; Material Rupture

    AS REPORTED, AN INDWELLING PICC (PLACEMENT DATE NOT KNOWN) WAS REMOVED AND REPLACED DUE TO "A RUPTURE IN THE CATHETER NEXT TO THE PROXIMAL HUB". NO PATIENT INJURY WAS REPORTED. IT WAS STATED THAT THE USED CATHETER WOULD BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8451149 ↗

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.