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BioFlo 45884Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Triple Lumen Catheter IR-145 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 H965458840), received between Jan 22, 2020 and Jan 22, 2020 — 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 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.

  • MalfunctionJan 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED: BIOFLO PASV 6F TL - PICC WAS PLACED (B)(6) 2020. PATIENT WAS SENT FOR X-RAY AND THE CENTER VALVE HAD FALLEN OFF THE HUB WITHIN 10 MINUTES OF BEING REPLACED. PATIENT WAS SENT BACK TO IR TO GET A NEW PICC PLACED. CENTER VALVE USED FOR CVP MONITORED DETACHED, RN RE-ATTACHED, BUT STILL REPLACED PICC AS A PRECAUTION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9617327 ↗

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