BioFlo 45831Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI H965458310), received between Mar 28, 2016 and Nov 10, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Crack” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL-55CM CATHETER KIT VALVED. THE NURSE REPORTED THAT THE PATIENT'S LINE WAS LEAKING ON THE WHITE LUMEN. IT WAS A WHITISH LEAKAGE AT THE CONNECTION PORT WHERE THE PATIENT'S PARENTERAL INFUSION IS ADMINISTERED. ON CLOSER INSPECTION, IT WAS NOTED THERE WAS A FRACTURE ON THE SEAM SECTION OF THE HUB. THE STAFF WAS INSTRUCTED TO NOT USE THE PICC AND THE PICC WAS ULTIMATELY REMOVED.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509725 ↗
• MalfunctionFeb 20, 2025Crack; Crack

  AN END USER NOTIFIED MHRA OF AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL-55CM CATHETER KIT VALVED. THE STAFF ON WARD REPORTED THAT THE TPN LUMEN CRACKED AND WAS LEAKING. TPN WAS ADMINISTERED THROUGH THE OTHER HUB. UNABLE TO USE THE GREY LUMEN, THE DEVICE 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 21422288 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL-55CM CATHETER KIT VALVED. IT WAS REPORTED THERE WERE CRACKS ON THE END OF THE PICC OF THE WHITE PORT SIDE USED FOR TPN. THE LINE WAS IN SITU FOR 5 DAYS WHEN THE STAFF REPORTED LEAKAGE. IT 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 21026632 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL-55CM CATHETER KIT VALVED. IT WAS REPORTED THERE WERE CRACKS ON THE END OF THE PICC OF THE WHITE PORT SIDE BEING USED FOR TPN. THE LINE WAS IN SITU FOR 53 DAYS, AND WAS REMOVED AND REPLACED. THIS WAS THE PATIENT'S THIRD LINE.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026631 ↗
• MalfunctionNov 13, 2023Crack; Crack

  2ND OCCURRENCE A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD.'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120950 ↗
• MalfunctionNov 13, 2023Crack; Crack

  5TH OCCURRENCE A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD.'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120930 ↗
• MalfunctionNov 13, 2023Crack; Crack

  4TH OCCURRENCE. A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD.'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120918 ↗
• MalfunctionNov 13, 2023Crack; Crack

  6TH OCCURRENCE A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD.'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120917 ↗
• MalfunctionNov 13, 2023Crack; Crack

  3RD OCCURRENCE: A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120913 ↗
• MalfunctionNov 13, 2023Crack; Crack

  1ST OCCURRENCE: A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICCS FROM BIO-STABLE 5F DL-55CM CATHETER KITS; VALVED. THE FEMALE SECTION OF THE PICCS CRACKING. THE DISTRIBUTOR'S PRODUCT MANAGER TEACHES 'FINGER TIGHT ONLY' BUT 6 HAVE CRACKED NOW ALL FROM THE SAME LOT. THE PICCS WERE REMOVED AND REPLACED. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THESE INCIDENTS. THE DISTRIBUTOR'S PRODUCT MANAGER FEELS IT COULD BE DUE TO THE OVERTIGHTENING OF THE "NFIVAD.'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120910 ↗
• MalfunctionOct 12, 2020Crack; Crack

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F PICC W/ PASV. IT WAS NOTED THAT THE HUB OF THE PATIENT'S PICC HAD A HAIRLINE CRACK AND WAS LEAKING. THE PICC WAS REMOVED AND THERE WAS NO REPORT OF ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. THE PICC LINE WAS BEING CARED FOR AND A "VYGON BIONECTOR" WAS USED TO COVER THE END OF THE PICC. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10667207 ↗
• MalfunctionOct 6, 2020Crack; Crack

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM CATHETER USED FOR TREATMENT OF BOWEL CANCER . A CRACK WAS DISCOVERED IN THE PICC VALVE AND LEAKING WAS NOTED ALONG THE CRACK, WHEN FLUSHED. THE WHITE LUMEN WAS DEDICATED FOR TPN USE ONLY; HOWEVER, IT WAS USED FOR FLUID INFUSIONS WHEN THE PATIENT WAS DISCHARGED FROM CHEMOTHERAPY. TPN WAS USED INITIALLY (ON THE WHITE LUMEN) AND THEN HAD FOLFIRI TREATMENT ON THE LUMEN THAT WAS NOT CRACKED (PURPLE). THE PICC IS FLUSHED ACCORDING TO TRUST POLICIES, WHICH IS A MINIMUM OF 10MLS NORMAL SALINE FOR EVERY ACCESS AND MINIMUM OF 20MLS IF BLOOD IS DRAWN. (WHITE LUMEN IS RESERVED SOLELY FOR TPN USE). THE DEVICE WAS REMOVED. IT IS REASONABLE TO CONCLUDE THE DEVICE WAS REPLACED IN ORDER FOR TREATMENT TO BE CONTINUED. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT, BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10634632 ↗
• MalfunctionMay 6, 2020Crack; Crack

  IT WAS REPORTED THAT A PATIENT'S BIO-FLO CATHETER PICC HUB CRACKED DURING INDWELL TREATMENT TIME WITH TOTAL PARENTERAL NUTRITION (TPN). THE PATIENT'S PICC WAS REPALCED TO RESOLVE THE REPORTED ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10029060 ↗
• MalfunctionMay 18, 2016Fracture; Fracture

  INDWELLING PICC, PLACED ON (B)(6) WAS REMOVED ON (B)(6) DUE TO A CRACKED HUB. IT WAS NOT STATED THAT THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5663133 ↗
• MalfunctionMay 18, 2016Fracture; Fracture

  INDWELLING PICC, PLACED ON (B)(6) WAS REMOVED ON (B)(6) DUE TO A CRACKED HUB. IT WAS NOT STATED THAT THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5663127 ↗
• MalfunctionMay 6, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY (B)(4) DISTRIBUTOR IN THE (B)(6), AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO LEAKAGE (POSSIBLY AT THE JUNCTION BETWEEN THE GREY HUB AND PURPLE VALVE). ONE OF THE ANESTHETISTS, WHO IS NEW, ATTEMPTED TO USE FORCEPS TO DISCONNECT THE GREY HUB FROM THE VALVE, NOT KNOWING THAT IT WAS BONDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636847 ↗
• MalfunctionMar 28, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5529854 ↗