BioFlo 45876Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965458760), received between Apr 18, 2022 and Jan 20, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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.

• MalfunctionJan 20, 2026Fracture; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT NON-VALVED. DURING PICC PLACEMENT, THE STAINLESS STEEL GUIDEWIRE FRACTURED INTO TWO SEPARATE PIECES INSIDE THE PATIENT. THE WIRE HAD UNRAVELED PRIOR TO FRACTURING DUE TO THE EXTENDED TIME OF MANIPULATING THE WIRE AND TRYING TO FREE IT FROM THE COLLATERAL. THEY WERE UNABLE TO REMOVE THE RETAINED FRAGMENT FROM THE PATIENT'S RIGHT ARM WITHIN THE COLLATERAL VEIN CONNECTED TO THE BRACHIAL VEIN. THE COLLATERAL WAS SMALL AND TORTUOUS, AND HAD SPASMED. THEY BELIEVE THE FRAGMENT WILL NOT MIGRATE FROM THAT POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS INFORMED OF THE EVENT AND REPORTED TO HAVE NO CONCERNS AT THAT TIME. IT HAD BEEN REPORTED THE PATIENT HAD A NICKEL ALLERGY. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 24116888 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A SENIOR CLINICAL RISK ADVISOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT. SOME TIME AFTER PLACEMENT OF THE DEVICE, THE PICC LINE TUBING DEVELOPED A HOLE IN THE STERILE, DRESSED PORTION OF THE TUBING; THUS RENDERING THE LINE INEFFECTIVE. IT IS UNKNOWN HOW OR WHEN THE HOLE OCCURRED; HOWEVER, THE PICC WAS REMOVED AND A PERIPHERAL INTRAVENOUS LINE (PIV) HAD TO BE INSERTED. THIS INHIBITED THE PATIENT FROM RECEIVING TPN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135570 ↗