MC2Recalls & reported problems across all models

We found 14 models of MC2 by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2023 and Dec 18, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MC2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 19, 2024Class IIOpen, Classified

   Potential for unsealed sterile packing.

   Z-1805-2024 · Root cause: Process control · names 10 of these models · Recall details · FDA record ↗

Most reported MC2 problems

MC2 models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MC2® 91246C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall1 report
• MC2® 91228

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall1 report
• MC2® 91240C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91236C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91263C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91263

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91251C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91251

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91246

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91229C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MC2® 91236

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• MC2® 91240

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• MC2® 91265

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• MC2® 91229

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report

Recent MC2 adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Contamination; Delivered as Unsterile Product; Contamination; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MC2 TWO STAGE VENOUS CANNULA, IT WAS REPORTED THE PACKAGING WAS DAMAGED. THE DEVICE WAS REPLACED WITH 91265 CANNULA. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A HOLE IN THE OUTER PACKAGING OF THE CANNULA. THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE PRODUCT WAS NOT USED. THE STERILE SEAL WAS INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL'. THE PACKAGE IS UNOPENED AND CANNOT BE CONFIRMED IF THERE WAS FOREIGN MATERIAL (FM) PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841843 ↗
• 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 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A KINKED MC2 TWO STAGE VENOUS CANNULA WAS DISCOVERED DURING A DE-CANNULATION PROCEDURE. THE SURGEON INDICATED THAT THE CANNULA APPEARED TO BE ACCEPTABLE AT THE START OF CANNULATION. THERE WAS NO VISIBLE EFFECT DURING SURGERY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376751 ↗
• MalfunctionSep 3, 2025Crack; Crack

  IT WAS REPORTED THAT DURING USE OF THE MC2 TWO STAGE VENOUS CANNULA IN THE MIDDLE OF A CASE, A CRACK WAS OBSERVED IN THE MIDDLE OF THE CANNULA. THE INNER LUMEN REMAINED INTACT AND THERE WAS NO BLOOD LOSS DUE TO THE CRACK. THERE WAS NO DAMAGE NOTED AT THE LOCATION OF THE SUTURES. THE CANNULA WAS CONTINUED TO BE USED THROUGHOUT THE CASE AND WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950876 ↗
• MalfunctionMay 28, 2025Contamination; Contamination

  IT WAS REPORTED THAT A BLACK HAIR WAS OBSERVED INSIDE THE UNOPENED STERILE PACKAGE OF A MC2 TWO STAGE VENOUS CANNULA. THE FOREIGN MATERIAL (FM) WAS VISIBLE THROUGH THE CLEAR PLASTIC MATERIAL. THE STERILE BARRIER REMAINED SEALED WHEN THE FOREIGN MATERIAL WAS IDENTIFIED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094568 ↗
• 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 ↗
• InjuryJan 8, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC2 TWO STAGE VENOUS CANNULA, IT WAS REPORTED DURING A REPAIR OF AN ASCENDING THORACIC ANEURYSM PROCEDURE UNDER CARDIOPULMONARY BYPASS, THE CUSTOMER LOST THE VENOUS DRAINAGE, SECONDARY TO THE FRACTURE OF THE VENOUS CANNULA. THE SITUATION CAUSED A VASCULAR AND HEMODYNAMICS COLLAPSE FOR ABOUT 2 MINUTES. THE CUSTOMER WAS ABLE TO RESOLVE IT IN ABOUT 2 MINUTES. THE PATIENT BLED APPROXIMATELY 800ML BESIDE THE CARDIOVASCULAR COLLAPSE WITH SEVERE HYPOTENSION AND VENTRICULAR FIBRILLATION. THE USE OF THE DEVICE WAS UNSPECIFIED.

  Patient problems: Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 21105972 ↗
• 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 ↗

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