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BioFlo 45893Recalls & reported problems

Navilyst Medical, Inc. · BioFlo PICC with Endexo and PASV Valve Technology - 6F x 55cm Triple Lumen 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 H965458930), received between Aug 7, 2019 and Aug 7, 2019 — classified as 1 malfunction.

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

  • Crack1

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 7, 2019Crack; Crack

    ANGIODYNAMICS' DISTRIBUTOR IN AUSTRALIA WAS CONTACTED BY A CLINICAL NURSE CONSULTANT FROM A HOSPITAL IN QLD VIA EMAIL AND ADVISED OF A COMPLAINT INVOLVING A BIOFLO PICC: "A HUB ON A 6FR 3L CRACKED RESULTING IN PATIENT REQUIRING A REPLACEMENT PICC". THE FEMALE PATIENT WAS (B)(6) AND WAS UNDERGOING CHEMOTHERAPY FOR ADENOCARCINOMA MID COLON. THE PICC HAD BEEN INSERTED (B)(6) 2019 VIA LEFT BASILIC VEIN UPPER 1/3 OF UPPER ARM PROXIMAL TO AXILLA IN ICU UNDER ASEPTIC TECHNIQUE. TIP POSITION CHECKED AND CONFIRMED ON MOBILE DIGITAL CXR. PICC SHORTENED 12CM AND INSERTED TO "0" MARK. RADIOLOGIST REPORT TIP AT SVC/RA JUNCTION. CRACK NOTED BY ONCOLOGY WHILE ACCESSING THE WHITE 19G SIDE LUMEN WITH BD - CAREFUSION MP1000C-00006 POSITIVE PRESSURE CONNECTOR. REMOVED (B)(6) 2019 PRIOR TO INSERTION OF NEW 2 LUMEN 5R 45-889 BIOFLO PICC CRACK DEMONSTRATED WHEN A SYRINGE WAS ATTACHED TO THE MP1000C CONNECTOR (BUNG) THE USED PICC WAS REPORTED AS BEING AVAILABLE FOR RETURN TO ANGIODYNAMICS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8870371 ↗

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