BioFlo Vortex CT80LPBDVIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787CT80LPBDVI0), received between Dec 16, 2020 and Mar 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Infusion or Flow Problem; Infusion or Flow Problem

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER. A FEW WEEKS FOLLOWING PORT PLACEMENT, THE PATIENT ARRIVED FOR A CHEMOTHERAPY INFUSION; HOWEVER, NURSES WERE UNABLE TO ESTABLISH BLOOD RETURN. THE PATIENT WAS UNABLE TO RECEIVE TREATMENT AND HAS BEEN SCHEDULED FOR A REMOVAL AND REPLACEMENT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827628 ↗
• MalfunctionNov 10, 2022Material Fragmentation; Material Fragmentation

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER. DURING A PLACEMENT PROCEDURE, THE INTRODUCER SHEATH DETACHED AND THE CATHETER SECTION BECAME LODGED IN THE PATIENT'S VESSEL. THE SURGEON WAS ABLE TO QUICKLY REMOVE ALL PIECES, USING A "MOSQUITO." ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15774725 ↗
• MalfunctionMar 21, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER. DURING A PROCEDURE, WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, UPON ACCESSING THE VESSEL WITH THE INTRODUCER, THE PHYSICIAN ADVANCED THE GUIDEWIRE INTO THE INTRODUCER NEEDLE. IT WAS ADVANCED, APPROXIMATELY 1" INTO THE VESSEL, AND THEN WOULD NOT ADVANCE FURTHER. THE PHYSICIAN ATTEMPTED TO WITHDRAWN THE GUIDEWIRE OUT OF THE INTRODUCER NEEDLE; HOWEVER, IT WAS STUCK. THE NEEDLE AND GUIDEWIRE WERE REMOVED AS ONE UNIT. IT WAS REPORTED THE GUIDEWIRE APPEARED INTACT, AND WAS ONLY "STUCK" INSIDE THE NEEDLE. DUE TO THIS ISSUE, AND NO ADDITIONAL KITS AVAILABLE, THE PROCEDURE WAS CANCELLED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK AS TREATMENT WAS NOT PROVIDED, BUT PATIENT HAD BEEN SEDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840064 ↗
• MalfunctionDec 16, 2020Stretched; Stretched

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE WITH AN 8F BIOFLO VORTEX PORT. DURING A PROCEDURE, THE WIRE WAS VERY DIFFICULT TO REMOVE FROM THE DEVICE. WHEN THE GUIDEWIRE WAS REMOVED, IT WAS NOTED IT HAD UNRAVELED. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME DEVICE, AND THERE WAS NO REPORT OF PATIENT HARM, OR ADVERSE EVENT AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER, AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024601 ↗