Medtronic Issues Urgent Class I Recall for Aortic Root Cannulas Due to Loose Particulate Risk

Source: Medical Device Business Review

Yesterday (March 31, 2025), according to an official notice released by the FDA, Medtronic is conducting a recall of its manufactured products.Aortic Root CannulationProducts such as these are subject to recall.Action, SummonReturn level isThe most severe level，AndInvolves withdrawal from sites currently in use or for sale，Means Series EquipmentMay cause serious injury or death。

Source: FDA official website

The public information shows that the male luer connector used in this catheter may pose a risk of unexpected loosening material. The loosened material may detach, potentially leading to serious adverse health consequences for patients, including injuries due to delayed treatment, stroke, and death.

The specific product information is as follows:

Recalled Product

• Product Name:

• DLP Aortic Root Cannula

  MiAR Cannula MiAR Cannula

  DLP Aortic Root Cannula with Vent Line

  
  

• Unique Device Identifier (UDI) Model:(For the full list, see the end of the article)

  DLP Aortic Root Cannulation:

  20613994495451/11012

  20613994495482/11014 

  MiAR Intubation:

  20613994495468/11012L

  20613994495499/11014L

  Aortic Root Cannula with Vent Tube:

  20613994495390/21012

  20613994495406/21014

Equipment Overview

The aortic root cannula series, part of Medtronic's cardiovascular product portfolio, is used for delivering cardioplegia and venting the aorta during cardiopulmonary bypass surgery.

These catheters have a dual-lumen tip, connected to a transparent body, and come with an isolated exhaust tube. All catheters are equipped with a stainless steel guiding needle.

Source: Medtronic official website

Medtronic sent an urgent medical device recall letter to all affected customers, recommending the following actions:

• Check the inventory of the affected product batches.

• Identify and isolate all unused affected products.

• Please call Medtronic Customer Service Returns at 1-800-854-3570, option 1 then option 4, to arrange the return of unused affected products and receive a refund. (The Medtronic sales representative at this facility can assist with the returns process if needed.)

• Fill out the customer confirmation form and send it by email to RS.CFQFCA@medtronic.com, even if the facility does not have affected products.

• Share this notification with others at your facility and other facilities that may receive affected products from your facility.

• Retain a copy of this letter as part of the facility records.

Attachment: Complete List of Affected Devices

(Swipe down to view)

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