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BioFlo 60M072131Recalls & reported problems

Navilyst Medical, Inc. · PICC Convenience 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 H96560M0721310), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

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

  • Uncoiled1

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.

  • MalfunctionFeb 2, 2018Uncoiled; Uncoiled

    AFTER PLACING A MIDLINE CATHETER IN THE PATIENT'S LEFT ARM, THE COMPLAINT REPORTER "WENT TO REMOVE THE GUIDEWIRE WITH THE INNER PART OF THE DILATOR AND THEY WERE BOTH COMING OUT AND AT THE VERY END...THE GUIDEWIRE WAS FLOPPY." IT APPEARED TO HAVE UNCOILED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7237369 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

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