BioFlo 45833Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Dual Lumen Catheter IR-145 Kit · Class 2 · Implant

All models of BioFlo (87)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965458330), received between Dec 27, 2024 and Aug 8, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Crack2
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 8, 2025Crack; Crack
AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO 5F DL-55CM IR-145 KIT VALVED. IT WAS REPORTED POST-PLACEMENT THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22758674 ↗
MalfunctionDec 27, 2024Crack; Crack
AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT VALVED. IT WAS REPORTED THE HUB CRACKED AND LEAKED ON A LINE THAT WAS ALREADY IN USE. THIS WAS NOTED WHEN THE NURSE WAS FLUSHING THE LINE. THE PICC REQUIRED REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026638 ↗
MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT VALVED. IT WAS REPORTED THE HUB BROKE OFF A LINE THAT WAS ALREADY IN USE. THE PICC REQUIRED REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026636 ↗

Device details

UDI-DI	`H965458330`
Brand	BioFlo
Model	45833
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 13, 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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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