BioFlo 75038Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965750380), received between Mar 23, 2017 and Feb 21, 2025 — classified as 1 injury, 6 malfunctions.

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

• MalfunctionFeb 21, 2025Crack; Crack

  AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W/70CM NITINOL WIRE. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438985 ↗
• MalfunctionJan 15, 2025Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W/70CM NITINOL WIRE. IT WAS REPORTED POST PLACEMENT, THAT THE PICC'S HUB WAS CRACKED. THE PICC REQUIRED REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160741 ↗
• MalfunctionOct 31, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING THE PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER KIT. THE PICC WAS REMOVED AFTER 7 DAYS DUE TO LEAKING AT THE PURPLE HUB. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. ADDITIONAL INFORMATION: PICC STARTED LEAKING AT THE PURPLE HUB. PATIENT WAS ON TPN. THEY THINK THE FLOOR NURSING STAFF WAS HAVING A HARD TIME GETTING THE NEEDLELESS CONNECTOR OFF. MAYBE TOO MUCH TWISTING FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041476 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE WITH A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W/70CM NITINOL WIRE. DURING A PROCEDURE, THE GUIDEWIRE BROKE WHEN IT WAS BENT OUTSIDE OF THE PATIENT'S BODY, BEHIND THE TUOHY BORST FOR PICC PLACEMENT. THE PICC NURSE BENDS THE WIRE TO "KEEP IT FROM MOVING." IT WAS REPORTED THE GUIDEWIRE HAD BEEN PLACED INSIDE THE CATHETER, WHICH WAS INSIDE THE PATIENT. THE FRACTURED WAS OUTSIDE OF THE PATIENT. NO FRAGMENTS WERE LEFT IN THE PATIENT AND GUIDEWIRE WAS REMOVED UPON COMPLETION OF PICC PLACEMENT.THE PROCEDURE WAS COMPLETED WITH THE PORTION THAT WAS STILL INSIDE THE CATHETER. THE NURSE NOTED THAT THE GUIDEWIRE IS DIFFERENT AND HAS SPOTS AND LARGER MARKINGS. THE SHORTER ACCESS WIRE HAS NOT CHANGED AND DOES NOT HAVE SPOTS ON IT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299949 ↗
• MalfunctionSep 25, 2017Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED, MIDLINE PICC PLACED IN UPPER RIGHT ARM ABOUT 24 HOURS PRIOR TO FAILURE. WHEN PLACED, IT WAS CONFIRMED WITH X-RAY TO BE IN GOOD POSITION IN THE DISTAL SVC. IT FLUSHED WELL AFTER INSERTION AND HAD GOOD BLOOD RETURN. THE NEXT DAY THE MIDLINE WOULD NOT FLUSH PROPERLY, AND HAD ISSUES RECEIVING A BLOOD RETURN. THE NURSE AT THE TIME COMPLAINED IT WAS HARD TO FLUSH AND ADMITTED TO PUSHING HARD ON THE SYRINGE. THE ANGIODYNAMICS CLINICAL SPECIALIST PRESENT WITH THE NURSE WAS SUSPICIOUS THAT SHE USED EXCESSIVE FORCE TO FLUSH THE CATHETER. HE ACCOMPANIED THE VASCULAR ACCESS NURSE TO THE BEDSIDE AND FOUND THE PICC TO BE LEAKING AT THE SITE. AS THE LINE WAS NEEDED TO ADMINISTER ANESTHESIA PRIOR TO SURGERY, THE MIDLINE WAS PULLED FROM UPPER RIGHT ARM AND REPLACED IN THE UPPER LEFT ARM AND THE NEW MIDLINE WORKED APPROPRIATELY. THE REMOVED PICC WAS FOUND TO CONTAIN A SLIT AT APPROXIMATELY THE 4-5 CM MARK. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6891721 ↗
• MalfunctionMay 17, 2017Difficult to Remove; Difficult to Remove

  AS REPORTED, ON USER/VOLUNTARY MEDWATCH MW5068658, "WHILE INSERTING THE PICC LINE, THE CATHETER BECAME CRIMPED WHEN ATTEMPTING TO REMOVE STYLET. SURGEON HAD TO COME AND REMOVE CATHETER SURGICALLY." IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6571958 ↗
• InjuryMar 23, 2017Kinked; Difficult to Remove

  WHILE INSERTING PICC LINE, THE CATHETER BECAME CRIMPED WHEN ATTEMPTING TO REMOVE WIRE STYLET. SURGEON HAD TO COME AND REMOVE CATHETER SURGICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6435768 ↗