BIO-MEDICUS® 96880-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000242343), received between Aug 21, 2024 and May 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

• InjuryMay 13, 2025Crack; Mechanical Problem; Crack; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULA WITH INSERTION KIT, A GUIDE WIRE (0.97MM X 180CM) FOR THE CANNULA WAS BEING USED TO CANNULATE A PATIENT FOR VENOVENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) (CV SURGERY) THROUGH THE RIGHT FEMORAL VEIN, RE-WIRING THROUGH A PREVIOUS DIALYSIS SITE. THE WIRE WAS INSERTED WITHOUT RESISTANCE INITIALLY, BUTRESISTANCE WAS NOTED DURING INSERTION AND REMOVAL. UPON REMOVAL, THE WIRE WAS FOUND TO BE SHREDDED AND SIGNIFICANTLY DAMAGED. ULTIMATELY, THIS DAMAGED THE PATIENT'S VENOUS SYSTEM (EXTERNAL ILIAC AND FEMORAL VEIN), RESULTING IN HEMORRHAGIC SHOCK THAT REQUIRED MASSIVE TRANSFUSION AND INTERVENTIONAL RADIOLOGY FOR MANAGEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22013931 ↗
• InjuryAug 21, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULA WITH INSERTION KIT, IT WAS REPORTED THAT IN THE INITIAL PROCEDURE, THE ATTENDING SURGEON WAS HOLDING DIGITAL PRESSURE ON THE INNOMINATE VEIN WHILE ANOTHER SURGEON ATTEMPTED RIGHT VENOUS CANNULIZATION. THE SURGEON COULD NOT ADVANCE THE WIRE OR REMOVE THE WIRE THROUGH THE SHEATH SO THE ENTIRE DEVICE WAS REMOVED. THE TEAM DID NOT VISUALISE THE WIRE PROTRUDING FROM THE TIP OF THE CANNULA. THE REMAINING WIRE WAS RETURNED TO THE WIRE HOOP TO CONTAIN ON THE FIELD. LATER IN THE CASE THE COUNT WAS OVER BY TWO NEEDLES AND A CHEST AND LEFT GROIN X-RAY WAS PERFORMED TO CLEAR THE COUNT. THERE WAS NO RSI SEEN BY THE RADIOLOGIST. THE CASE WAS POSTED TO REMOVE THE WIRE. THE WIRE WAS REMOVED BY VASCULAR SURGERY. THE SURGEON STATED THAT THE WIRE DID NOT NEED TO GO TO PATHOLOGY. THE CUSTOMER STATED THIS WAS AN EMERGENCY CASE. THE SCRUB TEAM DID RECOGNIZE THE WIRE LOOKED DIFFERENT BUT TO THE DEGREE THEY SPOKE UP IS NOT CLEAR. THE SURGEON WAS AWARE OF POTENTIAL WIRE PIECE RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 20023427 ↗