The U.S. Food and Drug Administration (FDA) has issued a recall for several Medtronic aortic root cannula devices due to safety risks. Affected devices, used in cardiopulmonary bypass procedures, are at risk of containing unexpected loose material in the male luer connector, which could lead to serious patient complications, including stroke and death.
Affected Devices:
- DLP Aortic Root Cannula – CFN 11012, CFN 11014
- MiAR Cannula – CFR 11012L, CFN 11014L
- DLP Aortic Root Cannula with Vent Line – CFN 21012, CFN 21014
Reason for Recall:
The loose material in these devices can become dislodged during use, causing delayed therapy, increasing the risk of stroke or even fatal outcomes. Fortunately, there have been no reports of injuries or deaths to date.
What to Do:
- Quarantine unused devices immediately.
- Contact Medtronic customer service to arrange returns.
- Inform colleagues and healthcare providers about the recall.
Impact on Patients:
Patients who have already been treated with these devices can continue with their normal care, with no changes recommended to their treatment plan.
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