BioFlo 60M010433Recalls & reported problems

Navilyst Medical, Inc. · PICC Convenience 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 H96560M0104330), received between Jul 12, 2016 and Jul 12, 2016 — classified as 1 malfunction.

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

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionJul 12, 2016Fracture; Fracture
AS REPORTED END USER HOSPITAL. INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. NO PATIENT COMPLICATIONS WERE REPORTED. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5787375 ↗

Device details

UDI-DI	`H96560M0104330`
Brand	BioFlo
Model	60M010433
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	Jan 16, 2023

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.