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BioFlo 60M183482Recalls & 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 H96560M1834820), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 malfunction.

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

  • Stretched1

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.

  • MalfunctionSep 7, 2017Stretched; Stretched

    AS REPORTED, PATIENT HAD PICC LINE PLACED (B)(6), 2017. LINE BECAME NON-FUNCTIONING. PICC LINE SERVICE NURSE REMOVED PICC LINE FROM PATIENT ON (B)(6) 2017 AND FOUND IT TO CONTAIN A SEGMENT WHICH APPEARED TO BE "DEFLATED AND STRETCHED." ANOTHER PICC LINE WAS PLACED. NO SAMPLE IS EXPECTED TO BE RETURNED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6848195 ↗

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.