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BioFlo 46-027Recalls & reported problems

Navilyst Medical, Inc. · BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965460270), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 injury.

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

  • Device Embedded In Tissue or Plaque1
  • Thrombosis/Thrombus1

Recent adverse event reports

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

  • InjurySep 1, 2021Fracture; Fracture

    EVENT DESCRIPTION UPDATED WITH ADDITIONAL INFORMATION: A DIRECTOR OF QUALITY/ RISK MANAGEMENT REPORTED AN ISSUE WITH A BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT W DF DRAPE AND TWO NIT PG. THE PATIENT REQUIRED A MIDLINE TO BE PLACED TO TREAT SEPSIS, NEEDING IV ABX. DURING AN INSERTION PROCEDURE, THE PATIENT'S VEIN WAS ACCESSED USING THE NEEDLE AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDEWIRE BUT THE PATIENT MOVED AND ACCESS WAS LOST. THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE; THEREFORE, AN INTERVENTIONAL RADIOLOGIST (IR) WENT TO THE PATIENT'S BEDSIDE TO EVALUATE. THE IR WAS ABLE TO REMOVE THE GUIDEWIRE; HOWEVER, THE TIP OF THE WIRE WAS NOT INTACT AND AN X-RAY REVEALED THAT A PIECE WAS REMAINING IN THAT PATIENT'S ARM. THE IR REMOVED THE WIRE TIP AND SERIAL XRAYS OF ARM AND CHEST WERE PERFORMED, AS WELL AS AN ULTRASOUND OF THE ARM WHICH REVEALED A THROMBUS. THE PROCEDURE/TREATMENT WAS ABORTED DUE TO THE THROMBUS, THEREFORE THE MIDLINE WAS NOT PLACED. THE PATIENT WAS THEN SENT TO (B)(6) MEDICAL CENTER FOR FURTHER EVALUATION OF THE THROMBUS ON (B)(6) 2021. ADDITIONAL INFORMATION REPORTED THAT AS OF AUGUST 31, 2021 THE PATIENT WAS STILL AT (B)(6) MEDICAL CENTER

    Patient problems: Device Embedded In Tissue or Plaque; Thrombosis/Thrombus

    MAUDE report 12407897 ↗

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.