BioFlo 02-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965103028050), received between Oct 16, 2020 and Mar 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN VIENNA AUSTRIA HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646054 ↗
• MalfunctionMar 30, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  A CLINICAL SPECIALIST MANAGER REPORTED A DISTRIBUTOR HAD BEEN NOTIFIED OF SIX EVENTS ASSOCIATED WITH BIOFLO DURAMAX DIALYSIS CATHETERS. THEY RELATED THAT SOME OF THE DIALYSIS SITES WHERE PATIENTS PRESENT IN VIENNA AUSTRIA HAVE EXPERIENCED "CRACKED/BROKEN HUBS" AND "AIR IN THE BLOODLINE" SUCH THAT THE CATHETERS HAD TO BE REPLACED. THEY INDICATED THERE HAVE BEEN 6 CATHETERS WITH THIS PROBLEM. NONE OF THE PATIENTS EXPERIENCED ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE INCIDENTS. IT WAS NOTED THAT THESE INSTANCES ONLY OCCURRED AT SITES AWAY FROM THE MAIN FACILITY WHERE THE PATIENTS RECEIVE HEMODIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645932 ↗
• MalfunctionOct 16, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPRESENTATIVE REPORTED TO AN ANGIODYNAMICS REPRESENTATIVE AN ONGOING ISSUE AN END USER HAS BEEN EXPERIENCING WITH BIOFLO DIALYSIS CATHETERS. PER THE DISTRIBUTOR: YESTERDAY I WAS VISITING A CUSTOMER WHO HAS PROBLEMS WITH THE BIOFLO DURAMAX CATHETER. THEY HAVE HAD SEVERAL INCIDENTS WITH LEAKING CATHETERS. THE LEAK WAS OFTEN NOT VISIBLE - SOME WERE HAIRLINE CRACKS OTHER HOLES COULD BE SEEN, ALWAYS NEXT TO THE LUER. THE LEAKS WERE DISCOVERED BECAUSE BLOOD LEAKED AND OTHER TIMES THE DIALYSIS MACHINE ALARMED BECAUSE AIR WAS ASPIRATED INTO THE EXTENSION LEG TUBING. IN SEVERAL CATHETERS THE LEAK HAS BEEN REPAIRED (INSTEAD OF CHANGED). HOWEVER, THE DEFECTIVE CATHETERS HAVE NOT BEEN SAVED, SO I CANNOT SEND THEM TO YOU. WE HAVE NO LOT/BATCH NUMBERS AVAILABLE. THERE HAS BEEN NO REPORTS OF PATIENT HARM OR INJURIES DUE THESE REPORTED MALFUNCTIONS. IT IS REASONABLE TO CONCLUDE THE DEVICES WERE REMOVED AND REPLACED IN ORDER TO CONTINUE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10690643 ↗