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BioFlo 75041Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Triple Lumen 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 H965750410), received between Oct 25, 2021 and Oct 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • MalfunctionOct 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    A CLINICAL NURSE MANAGER REPORTED AN ISSUE WITH A BIOFLO PICC (VALVED) 6FTL-55CM MAXIMAL BARRIER NURSING KIT W/70CM NITINOL WIRE. A FEW DAYS, POST PLACEMENT, THE HUB WAS FOUND TO BE DETACHED FROM THE CLEAR LUMEN. TREATMENT HAD BEEN PROVIDED APPROXIMATELY 2.5 HOURS BEFORE THE HUB WAS NOTED TO BE DETACHED. IT WAS UNKNOWN IF THE PICC HAD BEEN FLUSHED AFTER THE TREATMENT WAS PROVIDED. THE DEVICE WAS REMOVED BUT NOT REPLACED AS THE PATIENT NO LONGER NEEDS A PICC. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12688118 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.