BioFlo 02-904Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965103029040), received between May 10, 2016 and May 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

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

• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT PRESENTED FOR HEMODIALYSIS TREATMENT VIA A PREVIOUSLY PLACED BIOFLO 15.5F 28CM CHRONIC DIALYSIS CATHETER. THE CATHETER HAD NOT BEEN PLACED AT THIS TREATMENT FACILITY. DURING THE TREATMENT, THE PATIENT COUGHED AND THE BLUE VENOUS PORT OF THE CATHETER SEPARATED FROM THE TUBING, RESULTING IN A BLOOD LEAK. THE AMOUNT OF BLOOD LOSS CANNOT BE ESTIMATED; HOWEVER, IT WAS REPORTED TO HAVE BEEN SMALL DUE TO THE IMMEDIATE ACTION OF THE CLINICAN CLAMPING THE TUBING AND STOPPING THE DIALYSIS MACHINE. A LEUR PLUG WAS FORCED INTO THE END OF THE TUBING TO PREVENT FURTHER LEAKAGE. AT THAT TIME, THE PATIENT BECAME UNRESPONSIVE AND LOST CONSCIOUSNESS. A CODE BLUE WAS CALLED AND EMERGENCY TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT WAS ADMINISTERED NOREPINEPHRINE INFUSION 0.07 TO 0.36 MCG/KG/MIN AND DOPAMINE 5 TO 15 MCK/KG/MINUTE, WHICH WAS EFFECTIVE. LATER EXAMINATION OF THE DEVICE REVEALED THAT THE TUBING HAD A CLEAN SEPARATION FROM THE LUER FITTING. THE LUER FITTING WAS NOT RECOVERED; THEREFORE, IT IS UNKNOWN IF A PIECE OF TUBING WAS STILL ATTACHED TO IT. APPROXIMATELY 4 DAYS AFTER THE EVENT, THE CATHETER WAS REMOVED AND REPLACED WITH A DIFFERENT DEVICE. THE PATIENT WAS DISCHARGE F

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of consciousness

  MAUDE report 14278878 ↗
• MalfunctionMay 10, 2016Occlusion Within Device; Occlusion Within Device

  AS REPORTED, BIOFLO DIALYSIS CATHETER BECAME OCCLUDED AND WAS REMOVED AND REPLACED IN A PATIENT. PATIENT CONDITION WAS REPORTED AS, "UNAFFECTED." THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5644817 ↗