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BioFlo 02-808Recalls & reported problems

Navilyst Medical, Inc. · 15.5Fx48cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Basic Kit · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965103028080), received between May 31, 2016 and Mar 10, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

  • Fracture2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2017Fracture; Fracture

    EVENT OCCURRED IN (B)(6) - PATIENT HAD DIALYSIS CATHETER IMPLANTED ON (B)(6) 2016. CATHETER WAS REMOVED ON (B)(6) 2017 DUE TO LEAKAGE AT THE EXTENSION TUBING OF THE CATHETER. NO PATIENT COMPLICATIONS OTHER THAN CHANGING OUT THE CATHETER. THE PATIENT HAD BEEN CONNECTING THEMSELVES FOR HOME DIALYSIS FIVE TIMES PER WEEK. THE DRESSING WAS CHANGED EVERY 2 DAYS AND THE SITE WAS CLEANED WITH 70% ALCOHOL. TEGO CONNECTORS WERE USED FOR CONNECTION. THOSE WERE CHANGED ONCE PER WEEK AFTER A 30 SECOND SCRUB AND 2 MIN. DRYING TIME USING CHLORHEXIDINE WITH 4% ALCOHOL SOLUTION. THE CATHETER FROM THE REPORTED EVENT WAS DISCARDED BY THE HOSPITAL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6395976 ↗
  • MalfunctionMay 31, 2016Fracture; Fracture

    (B)(6) HOSPITAL HAS A PATIENT WITH A 48CM BIOFLO DURAMAX DIALYSIS CATHETER THAT DEVELOPED A LEAK AT THE JUNCTION POINT BETWEEN THE EXTENSION TUBES AND THE HUB. THE CATHETER WAS REPAIRED WITH A MEDCOMP REPAIR KIT, BUT WAS SLATED TO BE REMOVED AND REPLACED. THE REMOVAL WAS DELAYED BECAUSE THE PATIENT IS ON ANTICOAGULANTS. IT WAS STATED THAT THE USED CATHETER WOULD BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5688305 ↗

Other Catheter, hemodialysis, implanted devices

All Catheter, hemodialysis, implanted devices →

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