BioFlo 02-819Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965103028190), received between Jan 22, 2020 and Nov 10, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionNov 10, 2022Fracture; Fracture

  A CLINICAL MANAGER REPORTED AN ISSUE WITH A BIOFLO DURAMAX 15.5F 28CM DUAL VALVE SHEATH VASCPAK KIT. APPROXIMATELY 39 MINUTES INTO A HEMODIALYSIS TREATMENT, A BLOOD LEAK WAS DISCOVERED. CRACKS WERE DISCOVERED IN THE LUMEN OF THE CENTRAL VENOUS CATHETER (CVC); THEREFORE, TREATMENT WAS DISCONTINUED AND THE PATIENT WAS REFERRED FOR CVC REPLACEMENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 30 CC AND THE PATIENT DID NOT REQUIRE ANY HOSPITALIZATION DUE TO BLOOD LOSS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT AND HAD THE CVC REMOVED AND REPLACED. THE CATHETER HAD BEEN IN PLACE FOR APPROXIMATELY 2 YEARS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776902 ↗
• MalfunctionDec 3, 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 DEVICE. DURING PRIMARY PLACEMENT OF THE BIOFLO DURAMAX, THE DIALYSIS CATHETER TUBING DETACHED FROM THE TUNNELER AS THE PHYSICIAN WAS TUNNELING. THERE WAS NO REPORT OF 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 10938786 ↗
• 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 DEVICE. DURING PRIMARY PLACEMENT OF THE BIOFLO DURAMAX, THE DIALYSIS CATHETER TUBING DETACHED FROM THE TUNNELER AS THE PHYSICIAN WAS TUNNELING. THERE WAS NO REPORT OF 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 10928447 ↗
• MalfunctionAug 3, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT THIS BIOFLO CHRONIC DIALYSIS CATHETER WAS BROKEN WHERE THE TUBING MEETS THE END PART. THIS RESULTED IN THE PATIENT NEEDING TO HAVE THE CATHETER REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EVENT BECAUSE OF THIS ISSUE. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359279 ↗
• MalfunctionAug 3, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT THIS BIOFLO CHRONIC DIALYSIS CATHETER WAS BROKEN WHERE THE TUBING MEETS THE END PART. THIS RESULTED IN THE PATIENT NEEDING TO HAVE THE CATHETER REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EVENT BECAUSE OF THIS ISSUE. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359278 ↗
• MalfunctionJan 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE TUBING AT THE END OF THE CATHETER BROKE AT THE JUNCTION OF THE TUBING AND LINE EXTENSION. CATHETER WAS REPLACED WITH ANOTHER BIOFLO CATHETER. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9617325 ↗
• MalfunctionJan 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE TUBING AT THE END OF THE CATHETER BROKE AT THE JUNCTION OF THE TUBING AND LINE EXTENSION. CATHETER WAS REPLACED WITH ANOTHER BIOFLO CATHETER. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9617324 ↗