BioFlo 45882Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Technology - 5F x 55cm 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 H965458820), received between Feb 5, 2018 and Oct 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Backflow” (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. 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

Backflow1
Connection Problem1
Crack1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionOct 10, 2024Connection Problem; Connection Problem
AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F SL-55CM IR-145 KIT VALVED WITH NITINOL GW. THE END USER REPORTED THE FOLLOWING: PROBLEMS CONNECTING PICC LINE. EXPLANATION: PICC LINE INSERTED. IT DID NOT FUNCTION WHEN USED, EXCHANGED FOR NEW ONES. IT IS UNCLEAR IF THIS OCCURRED DURING PLACEMENT OR POST PROCEDURE AT THIS TIME. ADDITIONAL INFORMATION: WHEN THE COMPLAINT SAMPLE WAS RECEIVED, IT WAS COATED IN BIOMATERIAL AND EVIDENCE SHOWED IT HAD BEEN INDWELLING FOR AN UNKNOWN PERIOD OF TIME, THUS THE PROBLEM COULD NOT HAVE OCCURRED DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417274 ↗
MalfunctionFeb 24, 2022Crack; Crack
AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F SL-55CM IR-145 KIT. IT WAS REPORTED THAT DURING INDWELL, THE PICC'S PURPLE LUER LOCK WAS CRACKED AND WAS UNABLE TO BE USED. THE PICC WAS REMOVED AND THE PATIENT'S TREATMENT WAS PROVIDED PERIPHERALLY. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13591963 ↗
MalfunctionFeb 5, 2018Backflow; Backflow
AS REPORTED BY END USER HOSPITAL IN THE (B)(6), "SEVERAL DAYS AFTER INSERTION (OF A BIOFLO VALVED PICC) AFTER WITHDRAWL OF BLOOD, THERE WAS A CONTINUOUS BACKFLOW OF BLOOD." THE LINE WAS REMOVED AND REPLACED BY A SIMILAR DEVICE. THE USED PICC HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7241421 ↗

Device details

UDI-DI	`H965458820`
Brand	BioFlo
Model	45882
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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