Bio-Medicus™ CB96570-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000193362), received between May 14, 2021 and Jul 24, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 17 FR BIO-MEDICUS CANNULA, IT WAS REPORTED THAT THE CANNULA GUIDE CORE COULD NOT BE USED NORMALLY AND THE CANNULA COULD NOT BE DELIVERED OUT. THE USE OF THE CANNULA WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584996 ↗
• MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 17 FR BIO-MEDICUS CANNULA, IT WAS REPORTED THAT AFTER THE CANNULA WAS PLACED, BLEEDING WAS FOUND IN THE CANNULA BODY. AFTER REPLACING IT WITH A NEW CANNULA, THE CONDITION IMPROVED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22584941 ↗
• MalfunctionJul 18, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF TWO BIO-MEDICUS CANNULAE A 17FR AND A 15 FR, IT WAS REPORTED THAT THE CAPS WERE LOOSE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343608 ↗
• MalfunctionJul 17, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CB96570-017 BIO-MEDICUS CANNULAE, THE CUSTOMER OBSERVED THAT THE HEMOSTASIS CAP WAS LOOSE, RESULTING IN BLEEDING DURING CANNULATION. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: IT WAS ASKED BUT IS UNKNOWN WHETHER THE TWO DEVICES WERE USED DURING THE SAME PROCEDURE THE SECOND DEVICE WAS IN USE. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. THE ACCOUNT WAS NOT ABLE TO QUANTIFY HOW MUCH BLOOD LOSS IN ML OCCURRED DUE TO THE LEAK(S). NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331647 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE CUSTOMER REPORTED THAT TWO BIO-MEDICUS 17FR CANNULAE WERE OPENED, BUT THE RED CAPS WERE VERY LOOSE. A THIRD CANNULA WAS OPENED AND THE RED CAP SEEMED TO ¿SEAL¿ AS USUAL. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258631 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE CUSTOMER REPORTED THAT TWO BIO-MEDICUS 17FR CANNULAE WERE OPENED, BUT THE RED CAPS WERE VERY LOOSE. A THIRD CANNULA WAS OPENED AND THE RED CAP SEEMED TO ¿SEAL¿ AS USUAL. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258328 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CB96570-017 BIO-MEDICUS CANNULAE, THE CUSTOMER OBSERVED THAT THE HEMOSTASIS CAP WAS LOOSE, RESULTING IN BLEEDING DURING CANNULATION. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: IT WAS ASKED BUT IS UNKNOWN WHETHER THE TWO DEVICES WERE USED DURING THE SAME PROCEDURE THE SECOND DEVICE WAS IN USE. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. THE ACCOUNT WAS NOT ABLE TO QUANTIFY HOW MUCH BLOOD LOSS IN ML OCCURRED DUE TO THE LEAK(S). NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK(S)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255770 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICIUS CANNULAE THE CUSTOMER NOTED THAT THE RED CAP ON THE CANULAE DID NOT FIT TO THE 3/8 CONNECTION. THE CUSTOMER USED A THIRD CANNULA FROM A DIFFERENT LOT FOR THE PROCEDURE AND NO ISSUE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237080 ↗
• MalfunctionNov 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 17 FR BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT AFTER PUNCTURE, THERE WAS BLOOD OOZING AT THE PRODUCT PORT, WHICH MADE IT IMPOSSIBLE TO USE THE CANNULA AS USUAL. THE CANNULA WAS REPLACED. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUNCTURE REFERS TO THE INSERTION OF THE CANNULA INTO THE PATIENT. THE REPLACEMENT CANNULA WAS INSERTED IN THE SAME INSERTION SITE. THE AMOUNT OF BLOOD LOST BECAUSE OF THE ISSUE WITH THE CANNULA IS UNKNOWN. IT WAS ASKED BUT UNKNOWN WHETHER A TRANSFUSION WAS REQUIRED DUE TO THE BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15864197 ↗
• InjuryMay 14, 2021Material Rupture; Material Rupture

  MEDTRONIC RECEIVED INFORMATION THAT AFTER PLACEMENT OF A CB96570-017 BIO-MEDICUS ADULT FEMORAL CANNULA IN THE PATIENT'S RIGHT FEMORAL ARTERY, THE CUSTOMER STARTED ECMO REACHING A FLOW OF 2.3L/MIN. AFTER 3-4 MINUTES, THE SURGEON OBSERVED A RUPTURE OF THE CANNULA. THE CUSTOMER STATED IT SEEMED THAT THE CANNULA WAS SPLIT AT THE SUTURE POINT FIXING THE CANNULA TO THE TUBE. THE CUSTOMER CLAMPED THE ECMO AND THEN CHANGED THE ARTERIAL CANNULA OUT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824169 ↗