BioFlo 45968Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo Technology - 6F x 55cm Triple Lumen Catheter MST-70 Kit with Nitinol Wire · 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 H965459680), received between Jun 18, 2026 and Jun 18, 2026 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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.

MalfunctionJun 18, 2026Detachment of Device or Device Component
AN AUSTRALIA DISTRIBUTOR REPORTED AN ISSUE WITH BIOFLO PICC (NON-VALVED) 6FTL-55CM MST-70 KIT WITH NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT AN END-USER EXPERIENCED A HUB-CATHETER SEPARATION DURING A CT TEST FLUSH WITH SALINE AT 3 ML/SEC, BELOW THE DEVICE'S RATED FLOW. THE INJECTOR ALARMED FOR HIGH PRESSURE, FOLLOWED BY A "POP," AND THE PURPLE HUB WAS OBSERVED TO HAVE SEPARATED FROM THE CATHETER. THE LINE WAS IMMEDIATELY SECURED, AND THE PATIENT REMAINED STABLE WITH NO SIGNS OF HARM. THE PICC WAS SUBSEQUENTLY REMOVED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547950 ↗

Device details

UDI-DI	`H965459680`
Brand	BioFlo
Model	45968
Company	Navilyst Medical, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 17, 2021

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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