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BioFlo 45837Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Dual 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 H965458370), received between Jul 26, 2017 and Jul 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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

  • Malposition of Device1

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.

  • MalfunctionJul 26, 2017Malposition of Device; Malposition of Device

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A PICC LINE WAS INSERTED IN THE VENA CAVA AND THE POSITION WAS CONFIRMED. THE PATIENT WAS THEN SENT FOR A CT SCAN WHERE A DYNAMIC INJECTION OF CONTRAST - 325PSI @ 5MLS/SEC WAS PERFORMED. POST-SCAN NOTED THAT THE TIP OF THE PICC FLIPPED INTO THE INTERNAL JUGULAR VEIN. PICC WAS REMOVED AND REPLACED. PATIENT CONDITION WAS REPORTED AS "STABLE." IT WAS INDICATED THAT THE USED PICC WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6744554 ↗

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.