BioFlo 45802Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 3F x 55cm Catheter MST-70 Kit · Class 2 · Implant

All models of BioFlo (87)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965458020), received between Dec 27, 2024 and Jun 30, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (7 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Crack7

Patient problems

No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 30, 2025Crack; Crack
AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO PICC 3F SL-55CM MST-70 KIT VALVED PG. POST PLACEMENT, IT WAS NOTED THE HUB WAS CRACKED. THE PICC REQUIRED REMOVAL AND WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366446 ↗
MalfunctionJun 30, 2025Crack; Crack
AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO PICC 3F SL-55CM MST-70 KIT VALVED PG. POST PLACEMENT, IT WAS NOTED THE HUB WAS CRACKED. THE PICC REQUIRED REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366445 ↗
MalfunctionMar 1, 2025Crack; Crack
AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 KIT VALVED. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21499562 ↗
MalfunctionFeb 7, 2025Crack; Crack
AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 VALVED KIT. THE PATIENT HAD THE PICC PLACED ON (B)(6) 2024. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL AND REPLACEMENT. THE PICC WAS REMOVED AND REPLACED ON JANUARY 4, 2025. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21338276 ↗
MalfunctionDec 27, 2024Crack; Crack
A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 KIT VALVED. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026653 ↗
MalfunctionDec 27, 2024Crack; Crack
A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 KIT VALVED. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026647 ↗
MalfunctionDec 27, 2024Crack; Crack
A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 KIT VALVED. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026642 ↗

Device details

UDI-DI	`H965458020`
Brand	BioFlo
Model	45802
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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