Bio-Medicus™ CB96570-015 (UDI 00763000193355)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000193355), received between Jun 30, 2023 and Mar 10, 2026 — classified as 1 injury, 8 malfunctions.

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

• MalfunctionMar 10, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT IT HAD A KINK. 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 24557973 ↗
• MalfunctionNov 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE MODEL OF THE 15F ARTERIAL CANNULA DID NOT MATCH THE MODEL INDICATED ON THE EXTERNAL PACKAGING. ON THE MORNING, AT 9:30 A.M., AN OUT-OF-HOSPITAL ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED FOR A FAMILY CASE, AND ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) WAS INITIATED TO MAINTAIN CIRCULATION. THE CHIEF SURGEON INSTRUCTED THE TEAM TO PREPARE A 21F VENOUS CANNULA AND A 15F ARTERIAL CANNULA FOR VASCULAR PUNCTURE ACCORDING TO THE PATIENT'S CONDITION. DURING THE VERIFICATION PROCESS FOR THE HIGH-VALUE ARTERIOVENOUS CANNULA, IT WAS FOUND THAT THE MODEL OF THE 15F ARTERIAL CANNULA DID NOT MATCH THE MODEL INDICATED ON THE EXTERNAL PACKAGING (THE PACKAGING INDICATED 15F, BUT THE CANNULA INSIDE THE BOX WAS A BLUE-TIPPED 17F VENOUS CANNULA). THE CIRCULATING NURSE IMMEDIATELY REPORTED THIS TO THE CHIEF SURGEON. THE DEVICE WAS REPLACED WITH THE BACKUP 17F ARTERIAL CANNULA. THE PROCEDURE WAS COMPLETED, THE PATIENT WAS TRANSFERRED, AND RETURNED TO OUR DEPARTMENT. THE CUSTOMER STATED THAT THIS EVENT POSED A SIGNIFICANT SURGICAL SAFETY RISK AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463721 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT BLEEDING OCCURRED. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22661826 ↗
• MalfunctionJun 11, 2025Contamination; Contamination

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL/JUGULAR VENOUS CANNULA, IT WAS REPORTED THAT DURING THE MINIMALLY INVASIVE ATRIAL SEPTAL DEFECT AND TRICUSPID VALVE REPAIR SURGERY, EXTRACORPOREAL CIRCULATION WAS ESTABLISHED. AFTER OPENING THE PACKAGING BAG OF THE CANNULA, A HAIR WAS OBSERVED TO BE STUCK TO THE OPENING OF THE PACKAGING BAG. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185670 ↗
• MalfunctionDec 2, 2024Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA THE CUSTOMER REPORTED THROMBUS. THE DEVICE WAS R EPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817287 ↗
• InjuryAug 13, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT AT 7:00A.M. ON (B)(6) 2024, THE NURSE IN CHARGE OF THE BED FOUND THAT THE PATIENT'S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) COLLATERAL CIRCULATION THREE-WAY CONNECTOR WAS RUPTURED AND SPRAYED BLOOD. THE TUBE WAS BROKEN. UNDER STERILE CONDITIONS, COMPRESSION WAS APPLIED TO STOP THE BLEEDING IMMEDIATELY. IT WAS REPORTED TO THE DOCTOR AT THE SAME TIME. THE PATIENT'S VITAL SIGNS WERE CLOSELY OBSERVED. THE CRITICALLY ILL PATIENT'S BLOOD PRESSURE DROPPED FROM 130/75MMHG TO 108/54MMHG. NOREPINEPHRINE WAS IMMEDIATELY GIVEN TO MAINTAIN THEIR BLOOD PRESSURE. THE ECMO FLOW WAS ADJUSTED LOWER TO 1.5L/MIN. THIS ISSUE CAUSED THE PATIENT TO BLEED APPROXIMATELY 700ML. THERE WERE 4 UNITS OF LEUKOCYTE-REDUCED SUSPENDED RED BLOOD CELLS PREPARED FOR THE PATIENT. CONTINUED OBSERVATION AND TREATMENT WERE GIVEN TO THE PATIENT. UNDER STERILE OPERATION, THE DOCTOR WAS ASSISTED IN REPLACING THE ECMO COLLATERAL CIRCULATION THREE-WAY CONNECTOR AND THE 3/8 TUBE OF THE ARTERIAL CATHETER TO COMPLETE THE PROCEDURE.

  Patient problems: Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Myocardial Infarction

  MAUDE report 19972329 ↗
• MalfunctionAug 6, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE HAD BEEN IMPLANTED IN THE PATIENT'S BODY AND WAS READY TO BE AIR VENTED. IT WAS OBSERVED ON THE DEVICE THAT THE SIDE EXHAUST PORT CONNECTION WAS BROKEN. 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 19916110 ↗
• MalfunctionNov 2, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE PHYSICIAN ESTABLISHED EXTRACORPOREAL CIRCULATION FOR THE PATIENT. WHEN THE DEVICE WAS USED FOR INTUBATION, THE TUBE BODY AND THE INTRODUCER WERE ADHERED, AND THE INNER CORE COULD NOT BE PULLED OUT. THE DEVICE WAS REPLACED WITH A NEW DEVICE AND CONTINUED THE SURGERY. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT MAKE A NEW INSERTION SITE WHEN THE REPLACEMENT CANNULA WAS INSERTED, AS THEY USED THE INITIAL INSERTION SITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055145 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE DILATOR WAS NOT SNUG AND PUSHED UP OUT OF THE CANNULAE DURING INSERTION. THE PHYSICIAN WAS ABLE TO INSERT THE CANNULA SUCCESSFULLY. THE CANNULA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THERE WAS NO NOTICEABLE DAMAGE ON THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236796 ↗