BioFlo 75012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965750120), received between May 3, 2016 and Feb 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2019Obstruction of Flow; Obstruction of Flow

  AS REPORTED PICC LINE PLACED ON DEC 1. BY DEC 9, THE LINE WAS NOT ABLE TO BE INFUSED OR TO PROVIDE A BLOOD RETURN. AFTER PERFORMING AN OVER-THE-LINE REPLACEMENT, THE HOSPITAL EXAMINED THE PICC LINE UPON WITHDRAWL AND FOUND IT TO BE OCCLUDED PROXIMALLY. THE USED PICC WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304537 ↗
• MalfunctionMay 3, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, PICC WAS REMOVE AND REPLACED 4 DAYS AFTER INITIAL INSERTION DUE TO LEAKAGE (FREQUENT DRESSING CHANGES) NOTED AT THE INSERTION SITE. TROUBLE SHOOTING WAS PERFORMED (FLUSHING WITH NORMAL SALINE) AND CLEAR FLUIDS WERE NOTED COMING OUT FROM THE SITE.

  Patient problems: Fluid Discharge

  MAUDE report 5627055 ↗