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Xcela 45718Recalls & reported problems

Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 5Fx55cm Catheter IR-145 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 H965457180), received between Aug 31, 2021 and Aug 31, 2021 — 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

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionAug 31, 2021Fracture; Fracture

    AN END USER REPORTED AN ISSUE WITH A XCELA PASV 5F SL 55CM IR-145 KIT. A DAY AFTER THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE HAD DISLODGED INTO THE PATIENT'S MID-HUMERUS. THIS WAS ONLY NOTICED ONCE THE PATIENT RETURN TO A DIFFERENT HOSPITAL FOR A CHECK AND HAD AN ULTRASOUND PERFORMED. THE PIECE OF GUIDEWIRE WAS REMOVED THROUGH THE SAME ENTRY POINT; THEREFORE, SURGERY WAS NOT REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 12391825 ↗

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.