FDA announces new recall of Medtronic surgical devices over safety concerns
The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling multiple aortic root cannula devices due to ongoing safety risks. Any unused devices should be removed from the market and immediately returned to the manufacturer.
Devices included in this recall include Medtronic’s DLP Aortic Root Cannula, MiAR Cannula and DLP Aortic Root Cannula with Vent Line. These devices are used during cardiopulmonary bypass procedures to deliver cardioplegic solution or after the procedures to remove air from the patient’s aorta.
The reason behind the recall
Medtronic is recalling these devices due to an increased risk of “unexpected loose material” in the male luer of the cannula. If this occurs, the FDA warned, the result could potentially be fatal.
“The loose material has the potential to become dislodged and cause serious patient adverse health consequences, including injuries caused by delayed therapy, stroke and death,” according to the FDA advisory.
No serious injuries or deaths have been reported at this time.
What to do with unused devices
Any customers with unused devices should quarantine them immediately and then contact a Medtronic sales or customer service representative to arrange a return. Healthcare providers are also being asked to share this warning throughout their facilities and with other colleagues to ensure the message reaches as many clinicians as possible.
Patients already treated with these devices can be followed as normal; there are no recommended changes to the typical course of action.
The full list of impacted devices includes:
- DLP Aortic Root Cannula - CFN 11012
- DLP Aortic Root Cannula - CFN 11014
- MīAR Cannula CFR 11012L
- MīAR Cannula CFN 11014L
- DLP Aortic Root Cannula with Vent Line - CFN 21012
- DLP Aortic Root Cannula with Vent Line - CFN 21014
Click here to read the full advisory from Medtronic and the FDA.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.