Bio-Medicus™ 96570-119Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000116095), received between Sep 8, 2022 and Sep 20, 2026 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Crack” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834799 ↗
• MalfunctionDec 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT WHEN THE CUSTOMER WAS PREPARING FOR INTUBATION BEFORE SURGERY, THEY FOUND THAT THE PACKAGING INSIDE THE CANNULA WAS BROKEN. THE CUSTOMER WAS WORRIED THAT THE INTUBATION WAS CONTAMINATED. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775737 ↗
• MalfunctionJul 9, 2025Crack; Crack

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION, A VISIBLE CRACK WAS OBSERVED AT THE TUBING CONNECTION SITE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA PRIOR TO USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455746 ↗
• MalfunctionJun 16, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, A FRACTURE OCCURRED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210169 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE, A MANUFACTURING DEFECT AT THE TIP OF THE INTRODUCER OF THE BIO-MEDICUS CANNULA WOULD NOT ALLOW THE GUIDEWIRE TO PASS THROUGH. THE LOCATION OF THE DAMAGE WAS SPECIFIED AS THE TIP OF THE INTRODUCER. THERE WAS NO DAMAGE TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583853 ↗
• MalfunctionMay 1, 2024Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED WHILE INTUBATION WAS BEING PERFORMED, THE CUSTOMER OBSERVED THAT THE INTERFACE WAS SUSPECTED OF CRACKING. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219274 ↗
• MalfunctionFeb 22, 2024Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THEY PLACED THE DEVICE IN THE PATIENT SUCCESSFULLY. THE CUSTOMER REMOVED THE CAP FROM THE DEVICE CONNECTOR TO CONNECT IT TO THE HEART LUNG BYPASS MACHINE. AT THIS TIME, THE CUSTOMER NOTICED A CRACK IN THE CONNECTOR OF THE DEVICE. THE CUSTOMER DECIDED TO USE THE DEVICE AS THE PATIENT'S AORTA WAS DESCRIBED AS CRUNCHY AND THE CUSTOMER DID NOT WANT TO RECANNULATE. THE CRACK WAS SMALL AND COVERED BY THE BYPASS TUBING. THERE WAS NO BLOOD LOSS THAT OCCURRED BECAUSE OF THE CRACK. THERE WAS NO DAMAGE NOTED TO PACKAGING OR THE HOUSING OF THE DEVICE PRIOR TO USE. THERE WAS NO OTHER DAMAGE OBSERVED ON THE DEVICE. THE CASE WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND TWO CORONARY ARTERY BYPASS GRAFTS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756399 ↗
• MalfunctionSep 12, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THERE WERE STRESS MARKS OBSERVED ON THE CIRCUMFERENCE OF CANNULA AT CONNECTION SITE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727402 ↗
• MalfunctionJul 3, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONNECTOR WAS FOUND TO BE FRACTURED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER BOX OR STERILE BARRIER). NO OTHER DEVICES HAVE NOT BEEN DAMAGED. THE CUSTOMER STATED THE CONNECTOR WAS FRACTURED UPON OPENING THE PRODUCT HOWEVER, THE SALES REP STATED THAT THEY BELIEVE IT TO BE RELATING TO USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247854 ↗
• MalfunctionJun 12, 2023Component Missing; Misassembled During Installation; Component Missing; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT WHEN THE C ANNULAE WERE OPENED TO THE STERILE FIELD, THEY WERE FOUND TO HAVE A VERY LONG INTRODUCERS INCONSISTENT WITH THAT CANNULA MODEL AND NO CLEAR HEMOSTASIS CAPS. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO ADVERSE PATIENT EFFECTS. THE ISSUE WITH BOTH THE CANNULA WERE IDENTIFIED DURING THE SAME PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS IDENTIFIED AS SOON AS THE PACKAGING WAS OPENED. THE CANNULA WAS NOT ATTEMPTED TO BE USED WITH THE INCORRECT INTRODUCER. THE HEMOSTASIS CAP WAS NOT PROVIDED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BLOOD RESIDUE IS FROM BLOODY GLOVES HANDLING THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107406 ↗
• MalfunctionJun 12, 2023Component Missing; Misassembled During Installation; Component Missing; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULAE, IT WAS REPORTED THAT WHEN THE CANNULAE WERE OPENED TO THE STERILE FIELD, THEY WERE FOUND TO HAVE A VERY LONG INTRODUCERS INCONSISTENT WITH THAT CANNULA MODEL AND NO CLEAR HEMOSTASIS CAPS. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO ADVERSE PATIENT EFFECTS. THE ISSUE WITH BOTH THE CANNULAE WERE IDENTIFIED DURING THE SAME PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS IDENTIFIED AS SOON AS THE PACKAGING WAS OPENED. THE CANNULA WAS NOT ATTEMPTED TO BE USED WITH THE INCORRECT INTRODUCER. THE HEMOSTASIS CAP WAS NOT PROVIDED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BLOOD RESIDUE IS FROM BLOODY GLOVES HANDLING THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107388 ↗
• MalfunctionJun 9, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA AND KIT, IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED, THE MACHINE WAS RUNNING FOR ABOUT 3 HOURS WHEN THE TUBE WAS FOUND TO BE LEAKING BLOOD. THE DEVICE WAS IMMEDIATELY REPLACED TO COMPLETE THE PROCEDURE. UPON FURTHER INSPECTION, THE KNOB HOLE WAS FOUND TO BE CRACKED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17097157 ↗
• MalfunctionMay 12, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT THE DEVICE HAD A CRACK AND IT LEAKED BLOOD. USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16917812 ↗
• DeathMay 10, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULAE, IT WAS REPORTED THAT THE JUGULAR CANNULA DETACHED FROM THE PATIENT, WHICH CAUSED THEIR DEATH.  IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH LUNG FAILURE, AND WAS CONNECTED TO ECMO (VV FEM-JUGULAR). THE BIO-MEDICUS CANNULAE WERE BEING USED FOR DRAINAGE AND RETURN. ADDITIONAL INFORMATION RECEIVED CONFIRMS THE CAUSE OF DEATH WAS BLEEDING. THE PATIENT'S DEATH IS BELIEVED TO BE LINKED TO THE PERFOR MANCE OF THE JUGULAR CANNULA ONLY (96570-119). AFTER THE CANNULA DETACHED FROM THE PATIENT, THE HEALTH CARE PROFESSIONAL PERFORMED RESUSCITATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16900754 ↗
• InjuryFeb 8, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE CUSTOMER NOTICED A BLOOD LEAK DUE TO A CRACK AT THE LEVEL OF THE FEMALE CONNECTOR OF THE 3/8 CONNECTOR, CAUSING A LEAK AT THE CONNECTION OF THE FEMORAL PERFUSION. A 3/8 FITTING WAS USED TO STOP THE BLEEDING. THIS INCIDENT LED TO THE NEED FOR A MASSIVE TRANSFUSION TO THE PATIENT AND THE DISCONTINUATION OF EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CUSTOMER STATED THAT THE DAMAGE WAS IN THE LOCATION OF THE SUTURES. THE CUSTOMER STATED THAT THE AMOUNT OF PATIENT BLOOD LOST BECAUSE OF THE ISSUE WAS IMPORTANT BUT DIFFICULT TO ASSESS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16324622 ↗
• MalfunctionNov 21, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA AND KIT, IT WAS REPORTED THAT THERE WAS A CONNECTION CRACK. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833947 ↗
• MalfunctionSep 8, 2022Crack; Obstruction of Flow; Material Deformation; Crack; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN CANNULA, IT WAS REPORTED THAT THE CUSTOMER NOTICED SOME DAMAGE TO THE CONNECTOR ON THE CANNULA WHEN THE CANNULA WAS INSERTED INTO A PATIENT, AS IT WAS ABOUT TO BE CONNECTED TO THE BYPASS CIRCUIT. IT WAS REPORTED THAT THE PLASTIC LOOKED WHITE AS IF THERE HAD BEEN SOME PRESSURE UPON IT. THE CUSTOMER MADE THE DECISION NOT TO REMOVE THE CANNULA AND IT WAS CONNECTED TO THE BYPASS CIRCUIT. THE BYPASS RUN CONTINUED AND THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT POST-BYPASS WHEN THE CANNULA WAS INSPECTED, THERE WERE SOME CLOTS AROUND THE CONNECTOR OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380321 ↗