BioFlo 46490Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H965464900), received between Aug 19, 2020 and Apr 29, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A MIDLINE CATHETER FROM A BIOFLO MIDLINE 5F DL-20CM MAX STERILE BARRIER DRAPE KIT W/ TWO NITINOL GUIDEWIRE. NINE DAYS POST PROCEDURE, IT WAS REPORTED THE PATIENT'S MIDLINE HAD CRACKED ON THE HUB. THE MIDLINE CATHETER WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201830 ↗
• MalfunctionJan 24, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AN END USER REPORTED AN ISSUE WITH A BIOFLO MIDLINE 5F DL-20CM MAX STERILE BARRIER DRAPE KIT W/ TWO NITINOL GUIDEWIRES. IT WAS REPORTED THAT APPROXIMATELY 12 HOURS AFTER THE MIDLINE PLACEMENT, THE LINE WAS NOTED TO BE LEAKING AT THE CATHETER CONNECTION, WITH DUAL SPLIT. THE LINE WAS REMOVED AND REPLACED BEDSIDE WITH A NEW OF THE SAME DEVICE. THE SECOND DEVICE WAS INFUSED WITH NO ISSUES FOR THE REMAINDER OF THE PATIENT'S STAY, APPROXIMATELY 48 HOURS. IT WAS REPORTED THAT THERE WAS A SLIGHT DELAY IN THE ADMINISTRATION OF A SCHEDULED ANTIBIOTIC DUE TO THE ORIGINAL LINE LEAKING, HOWEVER THIS WAS ABLE TO BE RESCHEDULED BY PHARMACY ONCE A NEW LINE WAS INSERTED AND EFFECTIVE CARE WAS GIVEN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233059 ↗
• MalfunctionMay 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED AN ISSUE WITH A BIOFLO MIDLINE 5F DL-20CM MAX STERILE BARRIER DRAPE KIT W/ TWO NITINOL GUIDEWIRES. DURING A PROCEDURE, THERE WERE ISSUES WITH THE GUIDEWIRE AND PART OF THE WIRE WAS DISCOVERED TO BE LEFT IN THE PATIENT. THIS OCCURRED WHEN THE DOCTOR EXCHANGED A PICC WITH THE MIDLINE CATHETER. THE GUIDEWIRE FRAYED/UNRAVELED/STRETCHED AND PART OF IT BROKE OFF. THIS WAS NOTICED WHEN THE DOCTOR REGAINED ACCESS AT ANOTHER SITE AND IT SHOWED UP ON THE X-RAY. IT WAS REPORTED THERE WAS NO RESISTANCE WHILE TRYING TO REMOVE IT. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN OPTED TO LEAVE THE FRAGMENTS IN THE PATIENT AS IT WAS BELIEVED THE PATIENT WOULD EXPEL THE FRAGMENT; HOWEVER, THE PATIENT WILL BE OBSERVED AND HAS NOT EXPERIENCED ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11900215 ↗
• InjuryApr 6, 2021Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  AN IR DIRECTOR REPORTED AN ISSUE WITH A BIOFLO MIDLINE 5F DL-20CM MAX STERILE BARRIER DRAPE KIT W/ TWO NITINOL GUIDEWIRES. DURING THE PLACEMENT PROCEDURE, THE GUIDEWIRE GOT STUCK IN THE PATIENT'S VESSEL.. TWO DIFFERENT IR PHYSICIAN'S ATTEMPTED TO REMOVE THE GUIDEWIRE AND WERE UNSUCCESSFUL. AT THE TIME OF NOTIFICATION, THE PATIENT WAS CURRENTLY SCHEDULED TO GO TO SURGERY TO GET THE GUIDEWIRE REMOVED FROM THE VESSEL. ADDITIONAL INFORMATION REPORTED THE PATIENT UNDERWENT VASCULAR SURGERY AT WHICH TIME THEY WERE ABLE TO SUCCESSFULLY REMOVE THE GUIDEWIRE. WHEN THEY DID THE VASCULAR REMOVAL, THE PHYSICIAN USED THE SAME INSERTION SITE ON THE RIGHT SIDE OF THE ARM AS THE IR PHYSICIAN AND THE GW WAS RIGHT THERE IN THE VESSEL OF THE ARM AND WAS RETRIEVED. THE X-RAY SHOWS THE ENTIRE LENGTH OF THE GW GOES FROM THE INSERTION SITE ALL THE WAY TO THE HEART. IT'S A LONG WIRE. THE MIDLINE CATHETER ITSELF WAS NEVER INSERTED. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO REPORT OF PERMANENT PATIENT HARM OR INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11621951 ↗
• MalfunctionAug 19, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE DURING A MIDLINE INSERTION PROCEDURE. DURING THE PROCEDURE, THE ACCESS WIRE WAS STUCK IN THE PATIENT'S ARM. THE INSERTER OPTED TO HAVE A DOCTOR REMOVE THE WIRE; IT WAS INDICATED THE WIRE WAS PULLED BACK THROUGH THE ACCESS NEEDLE, HOWEVER, WHEN THIS WAS PERFORMED, A SMALL PIECE OF THE WIRE WAS RETAINED IN THE PATIENT'S ARM. THE FRAGMENT WAS NOT REMOVED AS IT WAS EMBEDDED IN THE PATIENT'S SOFT TISSUE. SURGERY HAD BEEN CONSULTED AND THE SURGEON DETERMINED REMOVAL WAS NOT NEEDED. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10424610 ↗