BioFlo 75036Recalls & reported problems
Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 4F x 55cm Catheter Maximal Barrier Nursing Kit (2 Nitinol Wires) · 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 H965750360), received between Nov 8, 2023 and Nov 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
Most reported problems
Device problems
- Crack1
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.
MalfunctionNov 8, 2023Crack; Crack
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 4FSL-55CM MAXIMAL BARRIER NURSING KI,T W/70CM NITINOL WIRE. THE PICC STARTED LEAKING AT THE PURPLE HUB DURING A TREATMENT SESSION. THE PATIENT WAS ON TPN. IT WAS THOUGHT THAT THE FLOOR NURSING STAFF WAS HAVING A HARD TIME GETTING THE NEEDLELESS CONNECTOR OFF AND USING TOO MUCH TWISTING FORCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18092807 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.