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BioFlo 75-050Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing 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 H965750500), received between Mar 21, 2022 and Mar 21, 2022 — classified as 1 malfunction.

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

  • Stretched1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 21, 2022Stretched; Stretched

    AN END USER REPORTED AN ISSUE WITH A BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. ONE WEEK AFTER PLACEMENT, THE PICC WAS REPORTED TO BE "BULGING." THIS WAS NOTICES UNDER X-RAY. RESISTANCE WAS FELT WHEN INFUSING MEDICATION AND ONLY ONE LUMEN HAD THE ABILITY TO FLUSH. DUE TO THESE ISSUES, IT WAS NOTED THAT FORCE HAD TO BE USED TO COMPLETE INFUSIONS. ULTIMATELY, THE DEVICE WAS REMOVED AND THE PATIENT HAD A NEW PICC PLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13840059 ↗

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.