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BioFlo 75031Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo Technology - 4F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires) · 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 H965750310), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • MalfunctionApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    AN END USER REPORTED AN ISSUE WITH A BIOFLO PICC (NV) 4FSL-55CM MAXIMAL BARRIER NURSING KIT. A PATIENT' S PICC WAS NOTED TO BE LEAKING FROM THE WHITE PART, BELOW THE HUB APPROXIMATELY 3 1/2 MONTHS POST PLACEMENT. THE PATIENT WAS RECEIVING TREATMENT VIA AN INFUSION PUMP AND THEN WAS RECEIVING IV FLUID AT HOME FOR HYDRATION. THE LEAK WAS REPORTED TO BE EMANATING DIRECTLY AT THE LUER AND TUBING JUNCTION. IT WAS REPORTED NO TOOLS WERE USED TO TIGHTEN THE CONNECTION FROM THE INFUSION PUMP TO THE LUER. THE CAP WAS CLEANED WITH ALCOHOL WIPE AND THE LUER WAS CLEANED WITH CLOHEXIDINE. THE PICC WAS REMOVED AND REPLACED WITH A DUAL LUMEN PICC. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14135576 ↗

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

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