BioFlo 03-819Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H965103038190), received between Jun 12, 2020 and Jan 13, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  1ST DEVICE, SAME PATIENT: A SENIOR MANAGER OF PATIENT SAFETY REPORTED AN ISSUE WITH A BIOFLO DIALYSIS CENTRAL VENOUS CATHETER. THE FOLLOWING WAS REPORTED: "CENTRAL VENOUS CATHETER PLACED ON (B)(6) 2022. ON (B)(6) 2022, CATHETER WAS LEAKING AT THE ARTERIAL LIMB AND REPAIR OF CVC TOOK PLACE ON (B)(6) 2022. (B)(4). PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS/HARM AS A RESULT OF THIS ISSUE (BLOOD LOSS, PROLONGED HOSPITALIZATION ETC. PT PRESENTED TO HEMODIALYSIS FACILITY ON (B)(6) 20/22 FOR REGULARLY SCHEDULED TREATMENT. TREATMENT INITIATED AT 557 AM. TREATMENT WAS UNEVENTFUL UNTIL 8:56 AM WHEN PATIENT ALERTED STAFF HE WAS BLEEDING. STAFF NOTED THE RED HUB OF THE CVC HAD DETACHED FROM THE LUMEN. TREATMENT WAS STOPPED. (B)(4). PT WAS TRANSPORTED TO THE HOSPITAL WHERE THE CLAMP AND HUB OF THE CVC WERE REPLACED. THE PATIENT LATER UNDERWENT A CATHETER EXCHANGE ON (B)(6) 2022".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157057 ↗
• MalfunctionJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  2ND DEVICE, SAME PATIENT: A SENIOR MANAGER OF PATIENT SAFETY REPORTED AN ISSUE WITH A BIOFLO DIALYSIS CENTRAL VENOUS CATHETER. THE FOLLOWING WAS REPORTED: "- CENTRAL VENOUS CATHETER PLACED (B)(6) 2022. - REPAIR OF CVC  TOOK PLACE 9/27/22 (B)(4). - PT PRESENTED TO HEMODIALYSIS FACILITY ON (B)(6) 2022 FOR REGULARLY SCHEDULED TREATMENT. TREATMENT INITIATED AT 557 AM. - TREATMENT WAS UNEVENTFUL UNTIL 856 AM WHEN PATIENT ALERTED STAFF HE WAS BLEEDING. - STAFF NOTED THE RED HUB OF THE CVC HAD DETACHED FROM THE LUMEN. TREATMENT WAS STOPPED. (B)(4). - PT WAS TRANSPORTED TO THE HOSPITAL WHERE THE CLAMP AND HUB OF THE CVC WERE REPLACED. - THE PATIENT LATER UNDERWENT A CATHETER EXCHANGE ON (B)(6) 2022 -PRE-EVENT HEMOGLOBIN 10.8 G/DL, POST EVENT HEMOGLOBIN 8.9 G/DL"

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16157056 ↗
• MalfunctionDec 6, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A BIOFLO CHRONIC DIALYSIS CATHETER 15.5F 28CM SINGLE VALVE SHEATH VASCPAK KIT. DURING A PROCEDURE, THE PHYSICIAN WAS TRYING TO PLACE THE DEVICE IN THE PATIENT AND EXPERIENCED ISSUES WITH THE INTRODUCER AND THE WHITE PLASTIC TRANSITION PIECE, FROM THE TUNNELER TO THE CATHETER. THE INTRODUCER SHEATH BUCKLED; THEREFORE, ANOTHER SAME DEVICE WAS OPENED. THIS PART OF THE DEVICE, FROM THE SECOND KIT, BROKE INTO A FEW PIECES INSIDE THE PATIENT; HOWEVER, THE PHYSICIAN WAS ABLE TO FISH THEM OUT AND THEN USE A THIRD KIT TO PLACE THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12933179 ↗
• MalfunctionJun 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT #2 AN IMAGING SUPERVISOR REPORTED THAT THE TUNNELER SLEEVE COMPONENT OF THIS BIOFLO CHRONIC DIALYSIS CATHETER SLID OFF THE TUNNELER AND BECOME DETACHED IN THE PATIENT WHILE TUNNELING WAS BEING PERFORMED. THE SLEEVE WAS ABLE TO BE REMOVED AFTER IT WAS NOTICED TO BE MISSING FROM THE TUNNELER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10148790 ↗
• MalfunctionJun 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT #3: AN IMAGING SUPERVISOR REPORTED THAT THE TUNNELER SLEEVE COMPONENT OF THIS BIOFLO CHRONIC DIALYSIS CATHETER SLID OFF THE TUNNELER AND BECOME DETACHED IN THE PATIENT WHILE TUNNELING WAS BEING PERFORMED. THE SLEEVE WAS ABLE TO BE REMOVED AFTER IT WAS NOTICED TO BE MISSING FROM THE TUNNELER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10148789 ↗
• MalfunctionJun 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT #1: AN IMAGING SUPERVISOR REPORTED THAT THE TUNNELER SLEEVE COMPONENT OF THIS BIOFLO CHRONIC DIALYSIS CATHETER SLID OFF THE TUNNELER AND BECOME DETACHED IN THE PATIENT WHILE TUNNELING WAS BEING PERFORMED. THE SLEEVE WAS ABLE TO BE REMOVED AFTER IT WAS NOTICED TO BE MISSING FROM THE TUNNELER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10148787 ↗