Bio-Medicus™ 96570-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169880764), received between Mar 15, 2022 and Sep 28, 2026 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K924642); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Deformation

  Medtronic received information that prior to use of a Bio-Medicus cannula, it was reported that the tube tip was damaged. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913181 ↗
• DeathJul 18, 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 THE CANNULA WAS FIXED WITH 0 PROLENE SUTURE AT THE CANNULA INSERTION SITE. ON 14 JULY 2024 THE PATIENT BEGAN WITH MINIMAL BLEEDING AT THE INSERTION SITE. HOWEVER, HEALING WAS PERFORMED, NO BLEEDING WAS IDENTIFIED FROM THE CANNULA DURING THE NIGHT. THE BLEEDING INCREASED UNTIL IT REACHED ABUNDANT PROFUSE BLEEDING, A REVIEW WAS PERFORMED BY THE CARDIOVASCULAR SURGEON, WHERE IT WAS EVIDENT THAT THE CANNULA WAS COMPLETELY FRACTURED AT THE LEVEL OF THE SUTURE. THE DEVICE WAS REPLACED URGENTLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19769605 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE CANNULA. THE DEFECT CAUSED BLOOD TO LEAK FROM THE DEVICE. THE ISSUE WAS OBSERVED DURING THE PREOPERATIVE CATHETERIZATION PROCESS. THE DEVICE WAS REPLACED IMMEDIATELY AFTER THE DISCOVERY TO COMPLETE THE PROCEDURE. 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. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THERE WAS NO AMOUNT OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. THERE WAS NO TRANSFUSION REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760491 ↗
• MalfunctionMay 22, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS BIO-MEDICUS CANNULA THE CANNULA TIP HAD A CRACK. THE CANNULA WAS SWAPPED OUT WITH A REPLACEMENT CANNULA AND THERE IS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE CRACK WAS NOTED WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE CANNULA INTO THE PATIENT. IT WAS NOTED THAT THE CRACK WAS NOT TOO BIG, BUT THE CANNULA WAS NOT ABLE TO BE INSERTED. THERE WAS NO LEAK NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973110 ↗
• MalfunctionOct 3, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT WHEN THE CANNULA WAS IMPLANTED IN THE PATIENT, THE TIP WAS FOUND TO BE ABNORMAL. SEE THE ATTACHED PHOTO. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT TIP WAS NOT OBSTRUCTED. CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE TIP WAS ENLARGED AND THE MEASURING HOLE WAS IRREGULAR. THE TIP/ PART OF THE TIP DID NOT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527117 ↗
• MalfunctionMar 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE CANNULA WAS LEAKING BLOOD FROM THE CONNECTION BETWEEN THE CANNULA AND A CONNECTOR. THE CANNULA WAS INSERTED IN THE FEMORAL ARTERY. IT WAS ASKED BUT UNKNOWN HOW MUCH BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE, AND THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13771575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924642. One submission often covers many models, so check the product and lot details in each record.

• Z-1928-2008 · May 9, 2008 · Terminated
  Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.