Medtronic Recalls Aortic Root Cannulas Due to Risk of Loose Material in Critical Component

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Medtronic recalls heart surgery cannulas over risk of loose material that could cause stroke or death.

Medtronic has issued a nationwide recall of multiple models of its Aortic Root Cannulas after identifying the potential presence of loose material in a key connector, which may lead to serious injuries or death if the devices are used. The recall affects several versions of the DLP Aortic Root Cannula, MiAR Cannula, and those with vent lines. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, the most serious type, indicating the devices pose a risk of severe harm.

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The issue stems from the male luer, a component of the cannula, where unexpected loose material could become dislodged during surgery. If this occurs, it may cause delayed therapy, stroke, or fatal outcomes. The affected cannulas are typically used for short durations during cardiopulmonary bypass surgery and to remove air from the aorta at the end of the procedure. Although no injuries or deaths have been reported to date, Medtronic has acted preemptively to mitigate potential risks.

As of February 5, 2025, Medtronic began notifying healthcare facilities with an Urgent Medical Device Recall letter. The company instructed healthcare providers to cease using any unused cannulas from the identified lots. Facilities are required to review their inventory, quarantine affected units, and contact Medtronic’s customer service to coordinate returns and credit processing. Facilities must also submit a Customer Confirmation Form regardless of whether affected products are in stock.

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Healthcare providers are advised to continue regular follow-up procedures for patients previously treated with these devices, as no additional risk is expected for past use. The recall applies to specific model numbers and lot codes listed under multiple product configurations, including those with and without vent lines.

Article by multiple RFHC contributors, based upon information from a Medtronic press release and the U.S. Food and Drug Administration.

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