MiAR™ Aortic Root Cannula with Flow-Guard™ 11014LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994495499), 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 this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K100274, K790565); 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 18, 2026.

Recalls naming this device

1. Feb 5, 2025Class IOpen, 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 · Recall details · FDA record ↗

2. Mar 19, 2024Class IIOpen, Classified

   Potential for unsealed sterile packing.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100274, K790565. One submission often covers many models, so check the product and lot details in each record.

• Z-0289-2025 · Oct 3, 2024 · Open, Classified
  Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery