BioFlo 75017Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H965750170), received between Aug 24, 2016 and Dec 27, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO PICC (VALVED) 4FSL-55CM MAXIMAL BARRIER NURSING KIT. APPROXIMATELY 3 WEEKS POST PLACEMENT, IT WAS NOTED THE HUB WAS CRACKED. THE PICC WAS BEING USED FOR TPN INFUSION. THE PICC REQUIRED REMOVAL, IT IS UNKNOWN IF IT WAS 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 21027158 ↗
• MalfunctionApr 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT PRESENTED FOR HER DAILY ANTIBIOTIC INFUSION VIA A PLACED PICC FROM A TANDEM BIOFLO PICC (VALVED) 4FSL-55CM MAXIMAL BARRIER NURSING KIT. WHILE PATIENT'S ANTIBIOTIC WAS INFUSING THROUGH HER PICC LINE, NURSING NOTICED THAT THE BIOPATCH WAS SATURATED WITH BLOOD, REQUIRING THE DRESSING TO BE CHANGED. AFTER DRESSING WAS CHANGED AND CLEAN, THE RN WAS ATTEMPTING TO CHANGE THE GREEN NEEDLE-LESS CONNECTOR ATTACHED TO THE PICC AND TIGHTEN IT IN PLACE, WHEN THE PURPLE HUB OF THE PICC LINE CRACKED. WHEN ATTEMPTING TO FLUSH THE LINE, NORMAL SALINE WAS LEAKING AROUND THE PURPLE HUB. IV THERAPY AND HOUSE SUPERVISOR WERE NOTIFIED OF THIS EVENT; NO ONE WAS AVAILABLE TO CHANGE THE PATIENT'S PICC LINE TODAY. ANOTHER RN REMOVED THE BROKEN PICC LINE, PER THE DOCTOR'S ORDERS. THE PATIENT IS SCHEDULED TO HAVE PICC LINE REPLACED ON (B)(6) 2023. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16832455 ↗
• MalfunctionSep 12, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  WHEN THE USER FACILITY RECEIVED SHIPMENT OF BIOSTABLE PICC KITS, AND WERE UNPACKING THE SHIPMENT, IT WAS NOTED ONE OF THE POUCHES WAS CUT IN A V ON THE CORNER. THERE WAS A TEAR, COMPROMISING THE PRODUCT STERILITY. THE REPORTED PACKAGE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9009752 ↗
• MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PER EVENT REPORT, : "THE PATIENT ARRIVED FOR INFUSION SERVICES WITH A BIOFLO 4 FRENCH, SINGLE LUMEN PICC. UPON INITIATING ASPIRATION FOR LABS, THE HUB PHYSICALLY DETACHED FROM THE CATHETER. THE NURSE USED A CLAMP ON THE CATHETER TO HELP STOP BLEEDING. THE NURSE THEN REMOVED THE PICC LINE AND REPLACED IT WITH A NEW BIOFLO 4 FRENCH SINGLE LUMEN PICC LINE. THE NEW LINE FUNCTIONED PROPERLY AND THERAPY WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT INJURY AND THE PATIENT'S STATUS IS FINE. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731561 ↗
• MalfunctionOct 17, 2017Crack; Crack

  AS REPORTED, THE HUB OF AN IMPLANTED PICC WAS NOTICED TO BE BROKEN ONE DAY AFTER INSERTION. THE PICC WAS REMOVED AND RETURNED TO ANGIODYNAMICS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955182 ↗
• MalfunctionAug 23, 2017Crack; Crack

  AS REPORTED, PICC HAD BEEN IMPLANTED IN PATIENT'S ARM UNDER ANESTHESIA ON (B)(6) 2017. WHEN IT WAS FIRST ATTEMPTED TO BE USED LATER THAT SAME DAY THE CATHETER LEAKED AT APPROXIMATELY THE 7CM MARK. THE DEVICE WAS REMOVED THAT DAY AND WAS NOT REPLACED. THE PATIENT CONDITION WAS LISTED AS "UNAFFECTED." IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813949 ↗
• InjuryMar 10, 2017Material Fragmentation; Material Fragmentation

  AS REPORTED: "NURSE WAS PLACING A BEDSIDE PICC. AFTER GAINING ACCESS WITH THE GREEN NEEDLE, THE NITINOL WIRE WOULDN'T THREAD. SHE PULLED THE WIRE & THE NEEDLE. SHE TRIED TO GAIN ACCESS IN THE SAME ARM IN A DIFFERENT LOCATION OF THE BRACHIAL VEIN. SHE GAINED ACCESS WITH A DIFFERENT NEEDLE (THE SAFETY NEEDLE) AND REINSERTED THE WIRE. THE WIRE HAD RESISTANCE AGAIN AND SHE COULDN'T ADVANCE. SHE ENDED UP PULLING THE WIRE AND IT STARTED TO UNRAVEL. BY THE TIME SHE PULLED THE WIRE OUT, THE TIP WAS COMPLETELY UNRAVELED AND PART OF THE WIRE BROKE OFF INTO THE PATIENT. SHE WAS ABLE TO RETRIEVE THE BROKEN PART OF THE WIRE, BUT WHEN THEY TOOK AN IMAGE, THEY FOUND OUT THAT A PART OF THE WIRE WAS LODGED IN THE PATIENT'S ARM. DUE TO THE FACT THAT THE WIRE WASN'T LODGED IN THE VESSEL, THEY DECIDED NOT TO ATTEMPT TO REMOVE IT. THE ACCOUNT HAD TO SCRAP THIS KIT AND OPEN ANOTHER KIT TO PLACE A PICC IN THE OTHER ARM."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6396261 ↗
• MalfunctionAug 24, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED, AN INDWELLING PICC WAS REMOVED DUE TO "LEAKAGE ABOVE THE WHITE HUB AT THE AREA OF THE TUBING CONNECTION. " THE PATIENT CONDITION WAS LISTED AS "UNAFFECTED," AND THE CATHETER WAS NOT REPLACED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5901005 ↗