Michigan Critical Care Consultants, Inc. 7080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10854916006383), received between Feb 12, 2025 and Jun 11, 2025 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Crack; Crack

  IT WAS REPORTED THAT DURING USE THERE WAS A CRACK AND BREAK IN THE WIRE WOUND PART OF THE SOFT-FLOW ANGLED TIP ARTERIAL CANNULA. THE SIZE OF THE CRACK/BREAK WAS NOT SPECIFIED, BUT IT WAS NOTED THAT THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE DEVICE WAS NOT REPLACED, AND ITS USE WAS CONTINUED TO COMPLETE THE CASE. 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. THE CANNULA DID NOT SLICE ALL THE WAY THROUGH, ONLY THE LAYER WITH THE WIRE OPENED BUT NOT THE ENTIRE CANNULA BODY. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182671 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WERE LOOSE CONNECTORS AT THE TOP OF TWO SOFT-FLOW ANGLED TIP ARTERIAL CANNULAE PRIOR TO USE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863481 ↗
• MalfunctionFeb 12, 2025Crack; Crack

  IT WAS REPORTED THAT THERE WAS A BREAK IN THE SOFT-FLOW ANGLED TIP ARTERIAL CANNULA WHILE ON CARDIOPULMONARY BYPASS. THE SEPARATION OCCURRED IN THE AORTIC CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HOSPITAL HAD CLOSED THEIR OWN INVESTIGATION ON THIS MATTER AND DETERMINED THERE WAS NO PATIENT IMPACT. THE CANNULA WAS NOT HEATED OR COOLED BEFORE USE. THERE WAS NO SUTURE AT THE LOCATION OF THE DAMAGE. THE AMOUNT OF BLOOD LOSS WAS REPORTED TO BE 100ML. A TRANSFUSION WAS NOT REQUIRED DUE TO THE INCIDENT.

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

  MAUDE report 21362491 ↗