BioFlo 03-804Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965103038040), received between Oct 7, 2016 and Jun 6, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  A CUSTOMER REPORTED AN ISSUE WITH A PATIENT'S CATHETER FROM A BIOFLO DURAMAX 15.5F 28CM SINGLE VALVE SHEATH BASIC KIT. DURING DIALYSIS, A CRACK WAS OBSERVED IN ONE OF THE LUMENS OF THE CATHETER AS IT LEAKED DURING FLUSHING AND AIR ASPIRATED WHEN THE CLAMPS WERE ON. IT WAS ALSO NOTED THAT THERE WERE LEAKS IN BETWEEN THE VENOUS ARM CONNECTOR AND TUBING. THE CATHETER HAD BEEN IN-SITU FOR APPROXIMATELY 9.5 MONTHS AND WAS USED 3X PER WEEK FOR TREATMENT. THE CRACKED CATHETER WAS REMOVED AND ATTEMPTED TO BE REPAIRED BY THE USER FACILITY BUT IT ONLY RESOLVED THE ISSUE FOR A FEW DAYS. ULTIMATELY, THE CATHETER WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND/MANUFACTURER DEVICE. THERE WAS NO INJURY TO THE PATIENT, HOWEVER THERE WERE DELAYS IN THE PATIENT RECEIVING TREATMENT DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071825 ↗
• MalfunctionSep 13, 2022Stretched; Stretched

  AN END USER REPORTED AN ISSUE WITH A BIOFLO DURAMAX 15.5F 28CM SINGLE VALVE SHEATH BASIC KIT. DURING A PLANNED EXCHANGE PROCEDURE, BECAUSE THE CATHETER HAD NOT BEEN FUNCTIONING PROPERLY, THE CATHETER WAS REMOVED AND FOUND TO BE BULGING AT THE PROXIMAL END. THE DEVICE WAS REPLACED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412717 ↗
• MalfunctionMay 6, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED BY END USER HOSPITAL IN (B)(6), A PINHOLE WAS DISCOVERED ON THE ARTERIAL CONNECTION PORT OF A BIOFLO DIALYSIS CATHETER. IT WAS LEAKING BLOOD. THE CATHETER HAD BEEN PLACED ON (B)(6) 2017 AND WAS REMOVED ON (B)(6) 2019. THE USED DEVICE WAS RETURNED TO ANGIODYNAMICS. THERE WAS NO REPORTED PATIENT INJURY OR COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8583902 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  ANGIODYNAMICS WAS MADE AWARE OF THIS EVENT WHICH OCCURRED DURING AN ADOPT STUDY OF THE BIOFLO DIALYSIS CATHETER IN (B)(6): AN INDWELLING BIOFLO DIALYSIS CATHETER WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. THE DEVICE WAS DISCARDED AND A NEW DIALYSIS CATHETER WAS PLACED ON THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257736 ↗
• MalfunctionJul 11, 2017Fracture; Fracture

  AS REPORTED BY A (B)(6) HOSPITAL, A DIALYSIS CATHETER WAS PLACED IN THE RIGHT IJ ON (B)(6)2015. A HOLE WAS NOTED IN THE EXTENSION LEG OF THE CATHETER ON AND IT WAS REMOVED AND REPLACED ON (B)(6) 2017. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6700708 ↗
• MalfunctionNov 10, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED BY HOSPITAL IN CANADA, PATIENT HAD HAD A BIOFLO DIALYSIS CATHETER PLACED ON (B)(6) 2016. CATHETER FELL OUT WHILE HE WAS TAKING A SHOWER AT HIS HOME ON (B)(6) 2016. THIS WAS NOT NOTICED UNTIL HE CAME IN TO THE HOSPITAL LATER THAT DAY FOR "EXTRA TREATMENT."PER THE COMPLAINT REPORTER, THE PATIENT'S CONDITION WAS DESCRIBED AS "STABLE." THE CATHETER WAS REPLACED ON (B)(6) 2016. THE USED CATHETER WAS DISCARDED / WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6092766 ↗
• MalfunctionOct 7, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A TUNNELED DIALYSIS CATHETER WAS REMOVED AND REPLACED BECAUSE THE PATIENT COMPLAINED OF "BURNING PAIN" AT THE TUNNEL SITE. NO FURTHER COMPLICATIONS WERE REPORTED. THE USED CATHETER WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Burning Sensation

  MAUDE report 6010773 ↗