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BioFlo 60M183481Recalls & 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 H96560M1834810), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (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

  • Hole In Material1

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.

  • MalfunctionApr 4, 2018Hole In Material; Hole In Material

    AS REPORTED, AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A HOLE WHICH WAS NOTED POST-PLACEMENT. IT WAS STATED THAT "THE PICC TEAM LEADER DID NOT FEEL AS IT WAS A DEFECT OF THE PRODUCT BUT RATHER DAMAGE TO THE DEVICE CAUSED BY SOMEONE NOT HANDLING IT PROPERLY." THE PATIENT CONDITION WAS LISTED AS, "UNAFFECTED." IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7395600 ↗

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.