MC2® 91236Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994887355), received between Feb 28, 2023 and Nov 28, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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

• MalfunctionNov 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE MC2 TWO STAGE VENOUS CANNULA, THE SURGEON CANNULATED WITH THE CANNULA AND OBSERVED THAT IT WAS STUCK UPON ATTEMPTING TO REMOVE THE STYLET. IT WOULD NOT COME OUT OF THE CANNULA. 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 23670049 ↗
• MalfunctionMay 12, 2025Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE OF AN MC2 TWO STAGE VENOUS CANNULA FOREIGN MATTER (FM) WAS OBSERVED IN THE DEVICE. THE FM APPEARS TO BE A HAIR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000571 ↗
• InjuryFeb 28, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC2 TWO STAGE VENOUS CANNULA, DURING CARDIOPULMONARY BYPASS, DRAINAGE DIFFICULTIES WERE OBSERVED AT THE LEVEL OF THE VENOUS RETURN. THE CUSTOMER STATED THAT CORRECTIVE MEASURES WERE UNDERTAKEN WHICH WERE OPTIMIZATION OF VASCULAR FILLING, TRANSFUSION AND SUPPLY OF PRESSOR AMINES. THE CUSTOMER OBSERVED THAT WHEN CARDIOPULMONARY BYPASS WAS STOPPED AND DURING DECANNULATION A BEND WAS OBSERVED ON THE CANNULA AT THE LEVEL OF THE ATRIAL POSITIONING EYELET. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO IMPACT TO THE PATIENT AFTER THE PROCEDURE. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES WERE DAMAGED IN THE SAME BOX/SHIPPING CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452359 ↗