MiAR Aortic Root Cannula with Flow-GuardRecalls & reported problems across all models

We found 2 models of MiAR Aortic Root Cannula with Flow-Guard by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2024 and Oct 23, 2025 — classified as 1 injury, 1 malfunction.

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

2 FDA recall records name at least one of these models by its device identifier, 2 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

MiAR Aortic Root Cannula with Flow-Guard 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. Feb 5, 2025Open, Classified

   Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

   Z-1306-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1800-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported MiAR Aortic Root Cannula with Flow-Guard problems

MiAR Aortic Root Cannula with Flow-Guard models

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

• MiAR™ Aortic Root Cannula with Flow-Guard™ 11014L

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  2 recalls2 reports
• MiAR™ Aortic Root Cannula with Flow-Guard™ 11012L

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports

Recent MiAR Aortic Root Cannula with Flow-Guard adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Manufacturing, Packaging or Shipping Problem; Packaging Problem; Misassembled During Installation; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MIAR CANNULA, THE CUSTOMER REPORTED THAT THE PRODUCT WAS OUT OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS NOT MISSING FROM THE PACKAGING. THE TIP SHEATH HAD COME OFF THE CANNULA, AND THE INTRODUCER NEEDLE WAS PROTRUDING THROUGH THE POUCH. THERE WAS DAMAGE TO THE PACKAGING, AND THE STERILE SEAL WAS NOT INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365748 ↗
• InjuryJan 25, 2024Contamination; Contamination

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS MINIMALLY INVASIVE AORTIC ROOT (MIAR), IT WAS REPORTED THAT AFTER GOING TO CONNECT THE CARDIOPLEGIA LINE TO THE CANNULA, IT HAD A SMALL PIECE OF PLASTIC INSIDE OF NEEDLE. IT WAS REPORTED THAT THE PLASTIC FLOATED UPWARDS WITH THE BLOOD, WHERE IT WAS REMOVED AND THE NEEDLE WAS RINSED THOROUGHLY WITH THE PATIENT¿S OWN BLOOD. THE CUSTOMER USED THE CARDIOPLEGIA NEEDLE FOR PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIER WAS NOT STILL SEALED WHEN THE FOREIGN MATERIAL WAS IDENTIFIED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ACCORDING TO THE HEALTH CARE PROFESSIONAL THAT WAS INVOLVED IN INCIDENT, THE LOOSE FRAGMENT COULD HAVE EMBOLIZED INTO THE PATIENT'S ARTERIAL CIRCULATION AFTER THE HEART-LUNG MACHINE WAS STARTED AND CAUSED DAMAGE AND ISCHEMIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578489 ↗

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