BioFlo 75015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965750150), received between Nov 18, 2016 and Nov 18, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED TO THE ED FOR EVALUATION OF A POTENTIALLY CLOTTED PICC. A DETERMINATION WAS MADE THAT A NEW DEVICE WOULD NEED TO BE PLACED. THE PICC ACCESS RN WAS CALLED FOR PLACEMENT. DURING PLACEMENT, GUIDEWIRE, WHICH HAD BEEN INSERTED INTO PEELABLE SHEATH, WAS NOT SECURED BY THE NURSE AND MIGRATED INTO THE PATIENT'S VASCULATURE. A CHEST X-RAY WAS TAKEN, CV SURGERY WAS CONSULTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. SURGICAL INTERVENTION WAS PERFORMED THE FOLLOWING MORNING, AND THE GUIDEWIRE WAS SUCCESSFULLY REMOVED PERCUTANEOUSLY. CONVERSATION WITH THE HOSPITAL QUALITY MANAGER HAS INDICATED THAT THIS IS BEING CONSIDERED AN ERROR IN TECHNIQUE BY THE RN.

  Patient problems: Foreign Body In Patient

  MAUDE report 6113430 ↗