BioFlo 03-803Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H965103038030), received between Apr 25, 2016 and May 10, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A VASCULAR SURGEON REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 24CM SINGLE VALVE SHEATH BASIC KIT. POST PROCEDURE, THE PATIENT WENT TO RECEIVE DIALYSIS, WHERE THE NURSES NOTED THAT THE EXTENSION TUBING WAS LEAKING. THE PATIENT WAS SENT BACK TO SURGERY TO HAVE THE CATHETER REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796822 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED THE END USER HAD A PROBLEM WITH A BIOFLO DURAMAX DIALYSIS CATHETER. DURING PLACEMENT OF THE BIOFLO DURAMAX, THE DIALYSIS CATHETER DETACHED FROM THE TUNNELER AND THE SLEEVE BROKE OFF THE TUNNELER, BECOMING STUCK INSIDE THE PATIENT. THE CATHETER SLEEVE WAS REMOVED WITH NO ADVERSE PATIENT EFFECT DUE TO THIS EVENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10928092 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED THE END USER HAD A PROBLEM WITH A BIOFLO DURAMAX DIALYSIS CATHETER. DURING PLACEMENT OF THE BIOFLO DURAMAX, THE DIALYSIS CATHETER DETACHED FROM THE TUNNELER AND THE SLEEVE BROKE OFF THE TUNNELER, BECOMING STUCK INSIDE THE PATIENT. THE CATHETER SLEEVE WAS REMOVED WITH NO ADVERSE PATIENT EFFECT DUE TO THIS EVENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10928007 ↗
• MalfunctionNov 3, 2017Fracture; Fracture

  AS REPORTED BY HOSPITAL IN (B)(6) BIOFLO DIALYSIS CATHETER PLACED IN PATIENT'S RIGHT INTERNAL JUGULAR ON (B)(6) 2015. IT DEVELOPED A HOLE UNDER THE LUER/HUB OF THE CATHETER AND WAS REMOVED ON (B)(6) 2017. NO PATIENT COMPLICATIONS WERE REPORTED. THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998723 ↗
• MalfunctionNov 3, 2017Fracture; Fracture

  AS REPORTED BY HOSPITAL IN (B)(6): BIOFLO DIALYSIS CATHETER PLACED IN PATIENT'S RIGHT INTERNAL JUGULAR ON (B)(6) 2016. IT DEVELOPED A HOLE INDER THE LUER/HUB OF THE CATHETER AND WAS REMOVED ON (B)(6) 2017. NO PATIENT COMPLICATIONS WERE REPORTED. THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998717 ↗
• MalfunctionJul 11, 2017Fracture; Fracture

  AS REPORTED BY A (B)(6) HOSPITAL, A DIALYSIS CATHETER WAS PLACED IN THE RIGHT SUBCLAVIAN ON (B)(6) 2015. BECAUSE OF A HOLE IN THE CATHETER EXTENSION TUBING THE DEVICE 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 6700706 ↗
• MalfunctionMar 1, 2017Fracture; Fracture

  BIOFLO DIALYSIS CATHETER PLACED ON (B)(6) 2015 VIA THE INTERNAL JUGULAR VEIN. THE CATHETER DEVELOPED A HOLE IN THE EXTENSION LEG AND WAS REMOVED ON (B)(6) 2017. THE EVENT OCCURRED IN (B)(6). THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6368906 ↗
• MalfunctionDec 19, 2016Fracture; Fracture

  AS REPORTED DIALYSIS CATHETER HAD BEEN PLACED IN THE PATIENT ON (B)(6) 2016. WHEN A HOLE WAS NOTED IN THE HUB OF THE EXTENSION TUBING ON (B)(6) 2016, THE CATHETER WAS REMOVED AND REPLACED. THE PATIENT CONDITION WAS REPORTED TO BE "UNAFFECTED" BY THE EVENT. THE USED DEVICE IS EXPECTED TO BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6187088 ↗
• MalfunctionDec 19, 2016Air Leak; Fracture; Air Leak; Fracture

  AS REPORTED DIALYSIS CATHETER HAD BEEN PLACED IN THE PATIENT'S RIGHT IJ ON (B)(6) 2016. THERE WERE NO COMPLICATIONS DURING INSERTION AND THE PATIENT, ON HOME HEMODIALYSIS, HAD NOT HAD ANY ISSUES INTIL THE NIGHT OF (B)(6) 2016, WHEN HER CIRCUIT FILLED WITH AIR. A HOLE WAS CONFIRMED WHEN THE PATIENT CAME IN FOR ASSESSMENT AND THE LINE WAS REPLACED. THE PATIENT CONDITION WAS REPORTED TO BE "UNAFFECTED" BY THE EVENT. THE USED DEVICE IS EXPECTED TO BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6187086 ↗
• MalfunctionOct 25, 2016Fracture; Fracture

  AS REPORTED BY END USER HOSPITAL IN (B)(6), A HOLE WAS NOTED IN THE EXTENSION LEG OF THE DIALYSIS CATHETER PLACED ON (B)(6) 2016. THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2016. THE PATIENT CONDITION IS REPORTED AS "UNAFFECTED." THE USED CATHETER IS EXPECTED TO BE RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6053369 ↗
• MalfunctionApr 25, 2016Fracture; Fracture

  AS REPORTED BY HOSPITAL IN (B)(6), AN INDWELLING DIALYSIS CATHETER WAS REMOVED AND REPLACED DUE TO A HOLE LOCATED "AT THE END OF THE EXTENSION TUBING ENDER THE END LUER CAP." THE PATIENT CONDITION WAS REPORTED AS BEING "UNAFFECTED" BY THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5605399 ↗