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BioFlo 60M701994Recalls & 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 H96560M7019940), received between Jul 19, 2019 and Jul 19, 2019 — classified as 1 malfunction.

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

  • 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.

  • MalfunctionJul 19, 2019Fracture; Fracture

    AS REPORTED BY HOSPITAL IN (B)(6), "WHEN BREAKING AWAY THE PEEL-AWAY PORTION OF THE INTRODUCER, BOTH HANDLE PORTIONS OF THE PLASTIC INTRODUCER BROKE OFF OF THE SHEATH BEFORE (B)(6) HAD COMPLETED THE PEEL AWAY FROM THE DILATOR. SHE WAS ABLE TO SUCCESSFULLY RETRIEVE ALL PORTIONS OF THE PEEL AWAY SHEATH BEFORE IT WENT UNDER THE SKIN ."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8807112 ↗

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.