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BioFlo 60M137906Recalls & 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 H96560M1379060), received between Oct 20, 2016 and Oct 20, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (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

  • Occlusion Within Device1

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.

  • MalfunctionOct 20, 2016Occlusion Within Device; Occlusion Within Device

    AS REPORTED, "A PICC LINE WAS INSERTED ON AN OUT-PATIENT FOR LONG TERM ANTIBIOTIC AND TWO WEEKS LATER HE RETURNED AND STATED THE LINE WAS OCCLUDED. WE DID TPA ON THE TWO PORTS AND WAS UNSUCCESSFUL. WE CAN HARDLY PULL BACK OR FLUSH, LET ALONE BLOOD RETURN AFTER THE TPA. THE LINE WAS REMOVED AND IN THE PROCESS WE NOTICED THAT THE LINE WAS TWISTED PRETTY BAD ALMOST TO A BREAKING POINT. " THE PATIENT CONDITION WAS LISTED AS "UNAFFECTED." THE USED CATHETER HAS BEEN RETURNED TO (B)(4) FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6043305 ↗

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.