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Vaxcel 45598Recalls & reported problems

Navilyst Medical, Inc. · Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Intermediate MST Kit · Class 2 · Implant

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M001455980), received between Apr 28, 2016 and Feb 21, 2020 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Crack1
  • Material Fragmentation1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 21, 2020Crack; Crack

    AS REPORTED: CALLED TO REVIEW PICC LINE ON WARD, AS LEAKING. LUER LOCK VALVE ATTACHED TO PASV ON BOTH LUMENS, OVER-TIGHTENED TO THE POINT THAT THE CASING OF THE PASV CRACKED AND IT WAS NOT POSSIBLE TO GIVE MEDICATIONS DUE TO LEAKAGE. POSSIBLE RISK OF AIR ENTRAINMENT AS UNABLE TO ASSESS DAMAGE TO VALVE. THE PICC WAS REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9740978 ↗
  • InjuryApr 28, 2016Material Fragmentation; Material Fragmentation

    AS REPORTED BY END USER HOSPITAL: "PICC LINE INSERTION ATTEMPTED IN THE RIGHT BASILIC INSERTION SITE. NEEDLE PLACED AND VERIFIED DARK COLOR WITH NO PULSATION. GUIDEWIRE STARTED AND MET RESISTANCE SO THE NURSE STOPPED IMMEDIATELY. STARTED TO REMOVE THE GUIDEWIRE, AS IT WAS BEING REMOVED THE WIRE STARTED SHREDDING. PRESSURE WAS HELD AT INSERTION SITE - REMOVED NEEDLE AND PART OF THE GUIDEWIRE STAYED IN THE RIGHT ARM." THE PATIENT WAS THEN SENT TO SURGERY FOR SUCCESSFUL REMOVAL OF THE GUIDEWIRE FRAGMENT. PER END USER, PATIENT EXPERIENCED "PROLONGED HOSPITAL STAY." THE USED DEVICE WILL NOT BE RETURNED, AS IT IS BEING RETAINED BY RISK MANAGEMENT, HOWEVER PHOTOGRAPHS WERE PROVIDED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 5617339 ↗

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

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Sources and updates

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