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BioFlo 45892Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Catheter MST-70 Kit with Nitinol Wire · 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 H965458920), received between Oct 24, 2020 and Oct 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

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 24, 2020Fracture; Fracture

    A RISK MANAGEMENT COORDINATOR REPORTED AN ISSUE WITH A BIO-STABLE 5F SL-55CM MST-70 KIT. A PATIENT PRESENTED FOR AN INDWELLING PICC CHECK AFTER THE PICC LINE LEAKED DURING FLUSHING. THE PICC LINE WAS FOUND TO HAVE A CRACK, LOCATED ABOUT 1CM BELOW THE PURPLE HUB, IN THE CLEAR TUBING. THE CRACK WAS CAUSING BLOOD TO BACK UP IN THE TUBING AS THE VALVE WAS NO LONGER FUNCTIONING EFFECTIVELY. THE PICC LINE WAS REMOVED INTACT AND WAS NOT REPLACED. THE PATIENT WILL COMPLETE TREATMENT USING A PERIPHERAL IV. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10731889 ↗

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.