BioFlo 75024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965750240), received between Jun 27, 2017 and Apr 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 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.

• MalfunctionApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN ISSUE WITH A BIOFLO PICC (NON-VALVED) 6FTL-55CM MAXIMAL BARRIER NURSING KIT. THIS KIT HAD A PROBE COVER PACKET THAT CONTAINED AN OPEN GEL PACK. THE NURSE REPORTED SUSTAINING A NEEDLE STICK FROM THE 6F KIT UPON CLEANUP OF THE "GOOEY MESS," IN THE TRAY. THE NEEDLESTICK WAS WITH A DIRTY NEEDLE. THE NURSE HAD LAB DRAWS DONE DUE TO RISK OF INFECTION. THE DRAWS ALL HAD NEGATIVE OUTCOMES. THERE WAS NO PERMANENT HARM OR INJURY TO THE NURSE DUE TO THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11648307 ↗
• MalfunctionJun 27, 2017Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED, "ONCE THE PICC WAS PLACED IN THE ER THE PATIENT WAS SENT TO ICU. AS SOON AS THE PATIENT GOT TO ICU, ONE OF THE TRIPLE LUMEN HUBS FELL OFF. ONCE THE PICC NURSE GOT TO THE ICU, A SECOND HUB FELL OFF. THE THIRD HUB WAS SECURE. THE PICC NURSE DID AN OVER-THE-WIRE EXCHANGE WITH A NEW PICC WITH THE SAME LOT NUMBER. SHE CHECKED THE HUBS PRIOR TO THE INSERTION AND THEY WERE SECURE." THE USED PICC WAS DISCARDED AT THE HOSPITAL, HOWEVER THE 2 DETACHED HUBS ARE BEING RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6670869 ↗