BioFlo 45894Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H965458940), received between Apr 20, 2018 and Jun 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A DISTRIBUTOR REPORTED A CUSTOMER COMPLAINT REGARDING A BIO-STABLE 3F SL-55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. ONE DAY FOLLOWING PICC PLACEMENT, WHEN NURSES INJECTED WATER THROUGH THE SYRINGE CONNECTOR, WATER WAS FOUND TO BE LEAKING FROM THE CATHETER LINE. THERE WAS NO RESISTANCE WHEN PUSHING WATER OR MEDICATION THROUGH THE DEVICE. ULTIMATELY, THE PATIENT REQUIRED REMOVAL AND REPLACEMENT OF THE DEVICE 6 DAYS LATER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292870 ↗
• MalfunctionJul 18, 2024Crack; Crack

  IT WAS REPORTED THAT "A 3 FR BIOFLO PICC WAS RECENTLY INSERTED ON A 2-WEEK INFANT. THE PURPLE HUB HAS CRACKED AND THE DEVICE NEEDS TO REPLACED." THE CRACK WAS FOUND TO HAVE OCCURRED AT THE AREA OF THE RIDGES THE WHERE THE NEEDLELESS ACCESS DEVICE SCREWS ON. THIS INCIDENT WAS NOTICED ON THE (B)(6) 2024 WHEN THE "BABY WAS CRYING, WHEN CHECKED PATIENTS' BLANKETS AND CLOTHING WERE SOAKED WITH PN & SMOF" CUSTOMER HAS ALSO ADVISED THAT A NEEDLESS CONNECTOR (LUER-LOCK) WAS CONNECTED TO THE HUB AT THE TIME THE ISSUE WAS NOTICED. THE BRAND NAME IS REPORTED TO BE: NANOCLAVE. THE PATIENT HAS HAD THEIR PICC REMOVED TODAY ((B)(6) 2024) UNDER GENERAL ANAESTHESIA AND HAS HAD A REPLACEMENT DEVICE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772640 ↗
• MalfunctionNov 6, 2023Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 3F SL-55CM MST-70 KIT, VALVED WITH NITINOL GUIDEWIRE, THE CUSTOMER REPORTED THAT THE PICC WAS REMOVED DUE TO A [?]FRACTURE' (I.E. CRACK) IN THE HUB. THIS INCIDENT WAS NOTICED ON THE (B)(6) WITH A PATIENT RECEIVING HOME PN. THE PICC WAS FIRST IMPLANTED IN THE PATIENT ON THE (B)(6)2023. THE EXACT CIRCUMSTANCES OF HOW THE ISSUE WAS FIRST NOTED WERE NOT ADVISED BY THE CUSTOMER IN THEIR REPORT. THE PICC WAS THEN REMOVED, AND WAS REPLACED WITH ANOTHER PICC. THERE WAS NO REPORTED INJURY/HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073651 ↗
• MalfunctionSep 19, 2018Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. WHILE THE EXACT IMPLANT AND EXPLANT DATES ARE NOT KNOWN, EXPLANTATION WAS ON OR EARLIER THAN (B)(6) 2018. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888884 ↗
• MalfunctionSep 19, 2018Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. WHILE THE EXACT IMPLANT AND EXPLANT DATES ARE NOT KNOWN, EXPLANTATION WAS ON OR EARLIER THAN (B)(6) 2018. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888883 ↗
• MalfunctionApr 20, 2018Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), AN INDWELLING PICC WAS REMOVED AND REPLACE DUE TO A HOLE LOCATED DISTAL TO THE SUTURE WING. NO PATIENT INJURY WAS REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446238 ↗