BioFlo 03-818Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H965103038180), received between Jun 4, 2018 and Apr 19, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT PRESENTED WITH A DEFECTIVE BIOFLO DURAMAX 15.5F 24CM SINGLE VALVE SHEATH DIALYSIS CATHETER THAT HAD BEEN PLACE APPROXIMATELY 6 MONTHS PRIOR. IT WAS REPORTED THE CATHETER WAS FAILING TO WORK AS INTENDED DUE TO MATERIAL BECOMING DEFECTIVE. THE PATIENT HAD BEEN REFERRED BACK TO THE PLACEMENT FACILITY BECAUSE IT WASN'T FUNCTIONING AND THAT IS WHEN IT WAS NOTED THE CATHETER WAS DAMAGED/DEFECTIVE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771832 ↗
• MalfunctionDec 2, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AN END USER REPORTED AN ISSUE WITH A GUIDEWIRE WHEN USING A DIALYSIS WITH BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM SINGLE VALVE SHEATH VASCPAK KIT. A GUIDEWIRE IS NOT SUPPLIED WITH THIS KIT AND IS OF UNKNOWN BRAND. THE GUIDEWIRE WAS KINKED DURING DILATOR EXCHANGES. MD NOTED RESISTANCE WHEN ADVANCING THE DILATOR UNDER FLUORO. THE DOCTOR NOTICED, UNDER FLOURO, THAT THE GUIDEWIRE WAS FRAYED. IT WAS NOTED, ON FLUORO, THAT THE INNER STRUCTURAL WIRE OF THE GUIDEWIRE WAS EXPOSED WHILE INSIDE THE BODY. THE ENTIRE WIRE WAS RETRIEVED/PULLED BACK INTO THE DILATOR AND REMOVED FROM BODY. IT WAS CONFIRMED THAT NO PART OF THE DEVICE FRAGMENTED OFF INSIDE THE PATIENT. THE PATIENT DENIED ANY COMPLAINTS OF CHEST PAIN OR SHORTNESS OF BREATH. ONCE THE WIRE WAS REMOVED, EXAMINATION OF THE DISTAL END OF THE DILATOR WAS NOTED TO HAVE FRACTURES/FISSURES/CUTS AFTER REMOVAL FROM BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919047 ↗
• MalfunctionNov 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: DR. (B)(6) DESCRIBED THIS ISSUE DURING TUNNELING THE CATHETER TUBING UNDER THE SKIN. WHEN THE TUNNELER SLEEVE REACHES THE DISTAL END OF THE TUNNEL (RIGHT BEFORE EXITING THE SKIN) HE IS ENCOUNTERING AN INCREASED RESISTANCE IN BEING ABLE TO PULL THE BACK OF THE TUNNELER WITH SLEEVE AND CATHETER TIP THROUGH THIS EXIT POINT. BECAUSE OF THIS INCREASE RESISTANCE HE IS PULLING HARDER ON THE TUNNELER SUCH THAT EITHER ONE OF TWO THINGS HAPPENS: THE TUNNELER PULLS THROUGH THE SLEEVE AND BRINGS CATHETER WITH IT LEAVING THE SLEEVE INSIDE THE TUNNEL. THIS THEN REQUIRES THE SLEEVE TO BE CUT/PEELED OFF. THE TUNNELER AND SLEEVE PULLS THROUGH THE TUNNEL AND CATHETER TUBING POPS OFF THE TUNNELER. THIS THEN REQUIRES STARTING TUNNELING PROCESS OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828183 ↗
• InjuryJul 23, 2020Break; Break

  AN END USER REPORTED THAT A PATIENT, WITH A BIOFLO DURAMAX CATHETER, WAS RECEIVING DIALYSIS TREATMENT WHEN THE MACHINE INDICATED THE PRESENCE OF "MICROBUBBLES." THE LINE WAS RUNNING AT 310. THE NURSE WAS ABLE TO RESOLVE THE FIRST ALARM; HOWEVER, IT OCCURRED AGAIN WITHIN AN HOUR AND MORE BUBBLES WERE VISIBLE IN THE EXTRACORPOREAL CIRCUIT. THE CAPS WERE CHANGED IN HOPES TO RESOLVE THE ISSUE; HOWEVER, DURING WITHDRAWING FROM THE RED LUMEN, FROTHY BLOOD WAS NOTED, AND THE TREATMENT WAS DISCONTINUED. THE PATIENT WAS READMITTED TO THE HOSPITAL TO HAVE THE DEVICE REMOVED AND A NEW, DIFFERENT DEVICE INSERTED. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10316900 ↗
• InjuryJul 23, 2020Break; Break

  AN END USER REPORTED THAT A PATIENT WAS TRANSITIONING OFF DIALYSIS, WITH A BIOFLO DURAMAX CATHETER, AND WAS RECEIVING WEEKLY LABS AND LINE CARE. THE LINE WAS HEPARIN-LOCKED. DURING LABS, A NURSE EXPERIENCED DIFFICULT WITHDRAWING BLOOD FROM THE CATHETER. THE LINE COLLAPSED ON WITHDRAWAL AND, EVENTUALLY, ONLY A SMALL AMOUNT OF BLOOD AND SALINE WAS WITHDRAWN. LOTS OF AIR BUBBLES WERE ALSO NOTED. THE PATIENT WAS READMITTED TO THE HOSPITAL TO HAVE THE DEVICE REMOVED. THE DEVICE WAS REPLACED WITH A COMPETITOR LINE. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10316861 ↗
• MalfunctionApr 27, 2020Crack; Crack

  A NURSE REPORTED WHEN USING A BIOFLO CHRONIC DIALYSIS CATHETER, BOTH LUMENS HAD SLUGGISH BLOOD RETURN AT THE START OF TREATMENT BUT FLUSHED WELL. FIRST DETECTION THAT THERE WAS AN ISSUE WAS THE DIALYSIS MACHINE ALARMING WITH "MICROBUBBLES". THE NURSE ATTEMPTED TO TROUBLESHOOT BUT CONTINUED TO GET A MACHINE ERROR. CAPS WERE CHANGED TO FURTHER TRY TO RESOLVE THE PROBLEM. WHEN WITHDRAWING BLOOD DURING THE CAP CHANGE, MORE BUBBLES WERE NOTED IN THE SYRINGE. AT THIS TIME, THE STAFF PHYSICIAN CHOSE TO TERMINATE TREATMENT ON ACCOUNT OF A POSSIBLE AIR LEAK. THE PATIENT WAS READMITTED TO THE HOSPITAL TO HAVE THE CATHETER REMOVED AND REPLACED. THERE WAS NO ADVERSE HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001266 ↗
• MalfunctionOct 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED: "WE HAVE A PATIENT WHOSE LINE SHOWED SIGNS OF ANEURYSMAL DILATATION AND RECENTLY STARTED LEAKING AT THE CONNECTION BETWEEN THE HUB AND THE LINE. THIS IS THE SECOND BIOFLO AND THE 2ND LEAK IN THE LINE THAT THIS PATIENT HAS EXPERIENCED" . THE LINE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. IT WAS INDICATED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. .

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9179122 ↗
• InjurySep 26, 2019Use of Device Problem; Use of Device Problem

  AS REPORTED: THEY WERE DOING A DIALYSIS CASE AND AS SOON AS THEY PUT IN THE SHEATH DILATOR IT WAS DRIPPING BLOOD. ONCE THEY PUT THE CATHETER IN IT WAS STILL DRIPPING BLOOD. AS THEY BROKE IT STARTED GUSHING BLOOD ALL OVER THE ROOM, ALL OVER (B)(6)'S FACE. THE VALVE JUST DID NOT WORK AT ALL. THIS EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS THERE WAS BLOOD (BIO CONTAMINATE) SPRAYED ON ONE OF THE NURSES IN ATTENDANCE. NO ADVERSE EFFECT TO THE ATTENDING NURSE WAS REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124794 ↗
• MalfunctionJun 20, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED, BY HOSPITAL IN (B)(6), APPROXIMATELY 5 MONTHS AFTER INSERTION DIALYSIS CATHETER BECAME "FLAT," AND THE HUB CRACKED, NECESSITATING REMOVAL AND REPLACEMENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE CATHETER FROM THE REPORT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8717312 ↗
• InjuryJun 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, FOLLOWING THE PLACEMENT OF A BIOFLO DIALYSIS CATHETER IN THE IJ, THE PATIENT "BLED FOR HOURS POST INSERTION." FURTHER DESCRIPTION - " IT ACCUMULATES UNDER THE SKIN AND OUT THE TUNNEL TRACT." THE CATHETER WAS REMOVED AND REPLACED, AND WAS DISPOSED OF AT THE HOSPTIAL.

  Patient problems: Blood Loss

  MAUDE report 7564994 ↗