BioFlo 75019Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI H965750190), received between Jun 12, 2018 and Mar 14, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Crack” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Crack; Crack

  AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. POST PLACEMENT, IT WAS NOTED THE HUB WAS CRACKED. THE PICC WAS BEING USED FOR TPN. 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 21606912 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. APPROXIMATELY 4 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 21027161 ↗
• MalfunctionOct 23, 2024Crack; Crack

  A SPECTRUM MEDICAL TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE PATIENT HAD THE PICC PLACED ON (B)(6) 2024. THE PICC WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO A HUB CRACK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514358 ↗
• MalfunctionOct 23, 2024Crack; Crack

  A SPECTRUM MEDICAL TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5 FDL - 55 CM MAXIMAL BARRIER NURSING KIT. THE PATIENT HAD THE PICC PLACED ON (B)(6) 2024. THE PICC WAS REMOVED AND REPLACED ON (B)(6) 2024, DUE TO A HUB CRACK. PATIENT REQUIRED AN EXCHANGE PROCEDURE AND WAS QUITE UNCOMFORTABLE AND UNHAPPY THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514313 ↗
• MalfunctionOct 23, 2024Crack; Crack

  A SPECTRUM MEDICAL TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5 FDL-55 CM MAXIMAL BARRIER NURSING KIT. THE PATIENT HAD THE PICC PLACED ON (B)(6) 2024.THE PICC WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO A HUB CRACK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514297 ↗
• MalfunctionSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, CATALOG NO.: CT80STPD, LOT NUMBER 4984172. UPON INFORMATION AND BELIEF, THE DEVICE WAS IMPLANTED BY (B)(6), CHEMOTHERAPY TREATMENT FOR BREAST CANCER. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), TO BE EVALUATED FOR A POSSIBLE PORT INFECTION, (B)(6) TEAM DETERMINED THAT THE PATIENT BE DISCHARGED AFTER SHOWING NO ADDITIONAL SIGNS OF REDNESS AND SWELLING AND SENT HOME WITH ANTIBIOTICS. ON OR ABOUT (B)(6) 2016, (B)(6), RETURNED TO (B)(6) AFTER EXPERIENCING WORSENING PAIN, IT WAS DETERMINED THAT DEFECTIVE PORT WAS INFECTED. UPON INFORMATION AND BELIEF, THE INFECTED PORT WAS THEN REMOVED BY (B)(6), AT THE SAME FACILITY. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, (B)(6) HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 20310736 ↗
• MalfunctionJun 11, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL-55CM IR-145 VALVED KIT. THE PATIENT HAD THE PICC PLACED ON (B)(6) 2024, AND WHEN THE PICC NURSE WAS PERFORMING A TPN INFUSION, IT WAS OBSERVED THAT THE HUB WAS CRACKED. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509065 ↗
• MalfunctionFeb 12, 2024Crack; Crack

  USER FACILITY MW REFERENCE (B)(4). ANGIODYNAMICS RECEIVED A USER FACILITY REPORT FROM AN END USER WHO EXPERIENCED ISSUES WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE PATIENT HAD WHIPPLE PROCEDURE AND HAD 5 FRENCH DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACED TO LEFT ARM FOR BLOOD DRAWS AND HOME TOTAL PARENTERAL NUTRITION (TPN). THE HOME HEALTH NURSE NOTED A CRACK IN THE PURPLE HUB WHEN TEACHING FAMILY ABOUT TPN HOME INFUSIONS. THE PATIENT WAS SENT TO THEIR LOCAL HOSPITAL FOR A PICC REPLACEMENT. THE PICC WASEXCHANGED WITHOUT DIFFICULTY BY INTERVENTIONAL RADIOLOGY (IR) NURSE OVER GUIDEWIRE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685181 ↗
• MalfunctionJan 4, 2024Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. DURING AN INFUSION TREATMENT SESSION, IT WAS NOTED THE PATIENT'S PICC LINE WAS LEAKING FROM THE GRAY HUB. THE HUB WAS CRACKED. THE PATIENT WAS REPORTED AS HAVING SEVERAL LINES IN THE PAST AS HE IS TPN DEPENDENT AND HAS BEEN IN AND OUT OF THE HOSPITAL FOR 3 TO 4 YEARS. THE LINE WAS REMOVED DUE TO THE CRACKED HUB, HOWEVER AT THIS TIME IT HAS NOT BEEN REPLACED AS THE ATTEMPT TO REPLACE IT FAILED. THEY WERE UNABLE TO INSERT A NEW PICC LINE DUE TO LOSS OF ACCESS WHILE WAITING FOR AN IR CONSULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444425 ↗
• MalfunctionJan 4, 2024Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE END USER NOTICED A PICC IN HER OFFICE THAT HAD A PURPLE HUB CRACK. THE EVENT HAD OCCURRED IN NOVEMBER. THE PATIENT WAS REPORTED AS TPN DEPENDENT. THE PICC WAS REMOVED DUE TO THE CRACK, AND REPLACED WITH A NEW OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444414 ↗
• MalfunctionNov 8, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PICC (NON-VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. IT WAS REPORTED THE HUB WAS FOUND TO BE CRACKED AT THE CLOSURE OF THE TPN INFUSION PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092608 ↗
• MalfunctionOct 10, 2023Crack; Crack

  AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO PASV 5F DL PICC MAXIMAL BARRIER KIT. DURING USE, IT WAS NOTICED THE HUB WAS CRACKED. DUE TO THE CRACK THE DEVICE WAS REMOVED AND REPLACED. THE CRACK WAS ON THE PURPLE HUB WHERE THEY ATTACH THE CLAVE, LENGTHWISE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905004 ↗
• MalfunctionAug 29, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO 5F DUAL LUMEN PASV MAX BARRIER KIT. THE PICC HUB CRACKED DURING TPN INFUSION. THE CATHETER WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644581 ↗
• MalfunctionAug 29, 2023Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE PATIENT'S CATHETER WAS REMOVED DUE TO IT NOT FUNCTIONING AS INTENDED. UPON EXAMINING THE REMOVED PICC, IT WAS NOTED THE CATHETER LINE WAS OCCLUDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644478 ↗
• MalfunctionAug 29, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE 5F DUAL LUMEN PICC WAS GETTING A TPN INFUSION AND THE HUB CRACKED. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644421 ↗
• MalfunctionAug 22, 2023Crack; Crack

  APPROXIMATELY 8 DAYS POST PLACEMENT, THE PATIENT'S 5F DL BIOFLO PASV PICC WAS OBSERVED TO HAVE A LEAK COMING FROM A HAIRLINE CRACK ON THE HUB OF THE DEVICE DURING TPN INFUSION. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS RECEIVING DAILY DOSE OF TPN. THE DEVICE WAS REPLACED WITH A NEW OF THE SAME. OF NOTE, STAFF REMEMBERS HE ASKED TO BE DISCONNECTED AND RECONNECTED MORE OFTEN THAN MOST PATIENTS, SUSPECT THIS HIGHLIGHTS SUSCEPTIBILITY TO CRACKING WITH REPETITIVE PLACEMENT/REMOVAL OF CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597841 ↗
• MalfunctionAug 22, 2023Crack; Crack

  APPROXIMATELY 4 DAYS POST PLACEMENT, THE PATIENT'S 5F DL BIOFLO PASV PICC WAS OBSERVED TO HAVE A LEAK COMING FROM A HAIRLINE CRACK ON THE HUB OF THE DEVICE DURING TPN INFUSION. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS RECEIVING DAILY DOSE OF TPN. OF NOTE, STAFF REMEMBERS HE ASKED TO BE DISCONNECTED AND RECONNECTED MORE OFTEN THAN MOST PATIENTS, SUSPECT THIS HIGHLIGHTS SUSCEPTIBILITY TO CRACKING WITH REPETITIVE PLACEMENT/REMOVAL OF CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597833 ↗
• MalfunctionAug 22, 2023Crack; Crack

  APPROXIMATELY ONE MONTH POST PLACEMENT, THE PATIENT'S 5F DL BIOFLO PASV PICC WAS OBSERVED TO HAVE A LEAK COMING FROM A HAIRLINE CRACK ON THE HUB OF THE DEVICE DURING TPN INFUSION. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. TPN WAS ADMINISTERED DAILY, AND NO TOOLS OR CLAMPS WERE USED FOR TIGHTENING CONNECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597832 ↗
• MalfunctionAug 22, 2023Crack; Crack

  APPROXIMATELY 3 DAYS POST PLACEMENT, THE PATIENT'S 5F DL BIOFLO PASV PICC WAS OBSERVED TO HAVE A LEAK COMING FROM A HAIRLINE CRACK ON THE HUB OF THE DEVICE DURING TPN INFUSION. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS RECEIVING DAILY DOSE OF TPN. THE DEVICE WAS REPLACED WITH A NEW OF THE SAME. OF NOTE, STAFF REMEMBERS HE ASKED TO BE DISCONNECTED AND RECONNECTED MORE OFTEN THAN MOST PATIENTS, SUSPECT THIS HIGHLIGHTS SUSCEPTIBILITY TO CRACKING WITH REPETITIVE PLACEMENT/REMOVAL OF CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597831 ↗
• MalfunctionAug 22, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE 5F DUAL LUMEN PICC WAS GETTING A TPN INFUSION AND THE HUB CRACKED. THE PICC WAS REMOVED AND REPLACED.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT. TPN IS ORDERED DAILY, ADMINISTERED NIGHTLY (EITHER CONTINUOUS OR CYCLIC). POLICY IS TO FLUSH THE LINE AFTER USE/COMPLETION OF THE BAG, AND THERE WERE NO REPORTS OF TOOLS USED TO TIGHTEN LINES, ALL STAFF INVOLVED IN DISCUSSION WITH REVIEW STATE THEY ATTACHED NEEDLELESS CONNECTORS AND TUBING WITH FINGER TIGHTENING ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597830 ↗
• MalfunctionAug 22, 2023Crack; Crack

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM A BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE 5F DUAL LUMEN PICC WAS GETTING A TPN INFUSION AND THE HUB CRACKED. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT. TPN IS ORDERED DAILY, ADMINISTERED NIGHTLY (EITHER CONTINUOUS OR CYCLIC). POLICY IS TO FLUSH THE LINE AFTER USE/COMPLETION OF THE BAG, AND THERE WERE NO REPORTS OF TOOLS USED TO TIGHTEN LINES, ALL STAFF INVOLVED IN DISCUSSION WITH REVIEW STATE THEY ATTACHED NEEDLELESS CONNECTORS AND TUBING WITH FINGER TIGHTENING ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597829 ↗
• MalfunctionAug 22, 2023Crack; Crack

  APPROXIMATELY ONE WEEK POST PLACEMENT OF THE PATIENT'S 5F DL BIOFLO PASV PICC, A LEAK WAS OBSERVED COMING FROM A HAIRLINE CRACK ON THE HUB OF THE DEVICE DURING TPN INFUSION. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THE DEVICE WAS USED DAILY FOR TPN USE, AND THERE WAS NO USE OF CLAMPS/TOOLS FOR TIGHTENING THE CONNECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597827 ↗
• InjuryJun 12, 2018Physical Property Issue; Physical Property Issue

  ANGIODYNAMICS WAS NOTIFIED BY (B)(4), THE SUPPLIER OF INTRODUCER SHEATHS, THAT THEY HAVE INITIATED A RECALL (1649395-05-02-2018-001-R) ON SPECIFIC DEVICE LOTS DUE TO "UNSAFE LEVELS OF BACTERIAL ENDOTOXINS (PYROGENS) THAT WERE INTRODUCED DURING A MANUFACTURING STEP." (B)(4) HAS INFORMED ANGIODYNAMICS THAT USE OF THE INTRODUCERS MAY EXPOSE PATIENTS/END USERS TO "BACTERIAL ENDOTOXINS, ALSO CALLED PYROGENIC BACTERIA THAT CAN ACTIVATE THE INFLAMMATORY PROCESS AND PRODUCE FEVER, CHILLS, AND HYPOTENSION IN A PATIENT." AS A RESULT OF THE (B)(4) RECALL, ANGIODYNAMICS IS CONDUCTING A VOLUNTARY RECALL (REMOVAL) OF THE AFFECTED ANGIODYNAMICS PRODUCTS. THE RECALL NOTIFICATION LETTERS WERE DELIVERED TO AFFECTED CONSIGNEES ON FRIDAY MAY 11, 2018. AFTER RECEIVING NOTIFICATION, THE END USER HOSPITAL HAS REPORTED: PICC ASSOCIATED WITH (B)(4) SHEATH RECALL (FOR BACTERIAL ENDOTOXINS) WAS PLACED IN A PATIENT ON (B)(6) 2018 IN THE MEDSURG UNIT. AT 2300 HOURS, THE PATIENT WAS TRANSFERRED TO ICU WITH A FEVER OF 103, HYPOXIA, AND HYPOTENSION. THEY DREW CULTURES FROM THE PICC AND A SEPARATE PERIPHERAL SITE. EIGHT HOURS POST RESULTS WERE NEGATIVE. (B)(6) - PATIENT HAD MANY COMPLICATIONS FROM RECTAL CANCER AN

  Patient problems: Fever; Unspecified Infection

  MAUDE report 7591593 ↗