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BioFlo 45842Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Triple Lumen Catheter MST-70 Kit · 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 H965458420), received between Aug 10, 2016 and Aug 10, 2016 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Backflow1
  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2016Backflow; Fracture; Backflow; Fracture

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), PATIENT HAD PICC INSERTED ON (B)(6) 2016. BECAUSE OF A LEAKING/CRACKED HUB, THE PICC WAS REMOVED AND REPLACED ON (B)(6) 2016. NO PATIENT INJURY WAS REPORTED. IT WAS INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5864481 ↗

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.