BIO-MEDICUS® 96880-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000242367), received between Jul 7, 2022 and Jul 24, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT DURING USE OF THE BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULA, THE SURGEON OBSERVED THAT THE CANNULA MATERIAL WAS SOFTER AT THE TUBING CONNECTION END COMPARED TO PREVIOUS EXPERIENCES WITH THE SAME TYPE OF CANNULA. THE END OF THE CANNULA KINKED, RESULTING IN OBSTRUCTED VENOUS FLOW. THE SURGEON WAS ABLE TO MANEUVER THE CANNULA SO THAT IT WAS NO LONGER KINKED, ALLOWING IT TO BE USED FOR THE REMAINDER OF THE CASE. THE SURGEON NOTED THAT THE CANNULA APPEARED TO BE MADE OF A DIFFERENT MATERIAL THAN PREVIOUSLY USED, AS PRIOR CANNULAE HAD NOT KINKED IN THIS MANNER. THE CUSTOMER QUERIED IF THE CANNULAE MATERIAL HAS CHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE BUT THE PATIENT¿S BLOOD WAS HEATED AND COOLED AND RUN THROUGH THE CANNULA. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS POSITIONED AT THE FEMORAL VEIN DURING USE. THE CANNULA WAS IN USE FOR 8 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586881 ↗
• MalfunctionJul 3, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF A BIO-MEDICUS MULTISTAGE FEMORAL VENOUS CANNULA, THE DEVICE FELT SOFTER THAN USUAL. THE SURGEON OPENED ANOTHER BOX TO CONFIRM IF THE CANNULA FELT SOFTER AT THE CLAMPING SITE THAN WHAT HE IS USED TO. THE SURGEON OBSERVED THE CANNULA WAS SOFTER THAN USUAL AND SHOWED HOW EASILY IT KINKED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393273 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Obstruction of Flow; Material Deformation; Mechanical Problem; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT DURING USE OF A BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA, THE CANNULA WAS OBSERVED TO BE VERY SOFT AT THE END, WHICH COULD BE CLAMPED, AND THE CANNULA KINKED, RESULTING IN RESTRICTED VENOUS DRAINAGE. THE SURGEON ADJUSTED THE INSERTION DEPTH OF THE CANNULA TO REMOVE THE KINK. THE SURGEON QUESTIONED WHETHER THERE HAD BEEN A MATERIAL CHANGE MAKING THE CANNULA SOFTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368873 ↗
• InjurySep 24, 2024Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULAE WITH INSERTION KIT, IT WAS REPORTED THAT DURING DE-CANNULATION, THE TIP OF THE CANNULA BROKE IN THE VESSEL, AND EMIGRATE RIGHT UP IN THE ATRIUM. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289786 ↗
• MalfunctionJul 3, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE BIO-MEDICUS MULTISTAGE FEMORAL VENOUS CANNULA'S GUIDEWIRE WOULD NOT PASS. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245253 ↗
• MalfunctionFeb 28, 2023Material Twisted/Bent; Material Twisted/Bent

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULA WITH INSERTION KIT, NO ISSUE WITH THE GUIDEWIRE WAS NOTICED WHEN REMOVING THE WIRE FROM THE PACKAGING. WHEN THE GUIDEWIRE WAS DEPLOYED, THE TIP WAS BENDING. THE CUSTOMER CHECKED THE WIRE AND FOUND THAT IT WAS BENDING AT THE TIP WHICH THE CUSTOMER STATED WAS NOT NORMAL. THE WIRE WAS STILL ABLE TO BE USED AND WHEN THE CANNULA BODY WAS DEPLOYED OVER THE WIRE THERE WAS NO FURTHER ISSUE USING THE CANNULA WITH THE WIRE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DAMAGE WAS NOT NOTICED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THE GUIDEWIRE WAS NOT REMOVED WHILE THE INTRODUCER NEEDLE REMAINED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452943 ↗
• MalfunctionJul 7, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS MULTI-STAGE FEMORAL VENOUS CANNULA WITH INSERTION KIT, IT WAS REPORTED THAT THE TIP OF THE INTRODUCER WAS BENT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THAT THE CANNULA WAS NORMAL AND THERE WAS NO HARM TO THE PATIENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS USED ACCORDING TO IFU STATEMENTS, NO HEATING OR COOLING WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945074 ↗