Medtronic Initiates Class I Recall of ECMO-Related Vascular Cannulas Due to Risk of Loose Materials in Luer Connectors

Apr 05, 2025 15:00 CST Updated 15:00

Medtronic

Medical Device Manufacturer

FDA Announces Action Against MedtronicLevel 1 Recall of Vascular Catheters: Medtronic Needs to Recall Relevant Products from Usage or Sales Locations. Continued Use of These Products May Lead to Serious Injury or Death.

Products Involved

DLP Aortic Root Cannula

MiAR Cannula

DLP Aortic Root Cannula with Vent Line

Product Use

The product is mainly used in cardiac surgery for connection with the artificial heart-lung machine (extracorporeal circulation), with a usage time not exceeding 6 hours. After the extracorporeal circulation ends, the cannula can also be used to remove air from the major artery (aorta).

Reason for Recall

There may be materials that could unexpectedly detach inside the luer connector (male luer) used for intubation. These detached materials may enter the patient's body, causing serious health hazards, including delayed treatment, stroke, and death.

Fortunately, at presentLuer ConnectorNo injuries or deaths have been reported as a result of the loosening.

Medtronic Measures

Suggestions for Doctors

According to the routine follow-up process, monitor patients who were previously treated with this device. Patients who have used the affected device in the past are not at additional risk.

Suggestions for Hospitals

Check the products from the affected batches in the inventory;

Identify and isolate all unused affected products。