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.
Continues after this brief message…
Did you know? Paid supporters get a reduced ad experience!
We know you value local news and entertainment that is free, open, and independent. Producing high-quality, paywall-free content isn't free. It takes time, effort, and resources to keep you informed and entertained. Unlike corporate media, we don’t have deep-pocketed investors or big advertisers funding our work—we rely on you, our readers and listeners, to keep Radio Free Hub City running. We're literally running on a shoe-string budget, but keep working hard to provide as much news and entertainment as we can.
If just 5% of local area residents became paid supporters at only $5 per month, we could meet our fundraising goals and continue expanding our news coverage depth while continuing to provide free access for everyone. So, if you'd like to help us in our continuing quest to improve our coverage, please consider becoming a paying supporter.
Will you be one of the 5%?
Thank you for supporting Radio Free Hub City!
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.
Article continues after these messages…
While other outlets focus on getting quotes from politicians who don't even live in our congressional district, we're focused on providing the hard-hitting truths and facts without political spin. We don't lock our news behind a paywall, will you help us keep it that way? If you're tired of news sweetened with confirmation bias, consider becoming a monthly supporter. But if you're not, that's fine too—we're confident in our mission and will be here if you decide you're ready for the truth. Just $5/month helps fund our local reporting, live election night coverage, and more.
Become a paid supporter for reduced ad experience!
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.
Do you believe we got something wrong? Please read our publishing standards and corrections policy.
Did you know? Supporters get a reduced ad experience!
Sponsored Articles
Get daily and breaking news for Washington County, MD area from Radio Free Hub City. Sign up with your email today!
Paid supporters have a reduced ad experience!
Discover more from Radio Free Hub City
Subscribe to get the latest posts sent to your email.