Medtronic Recall Issued for Open Heart Surgery Device With Loose Materials That Could Injure Patients

Devices are used with cardiopulmonary bypass machines, which temporarily take over heart and lung functions during surgeries.

Federal health officials indicate that a recall has been issued for certain aortic root cannula devices, due to loose materials being found in device fittings, which could be released into the patient’s body during surgery.

The U.S. Food and Drug Administration (FDA) announced the Medtronic vascular cannula recall on March 31, indicating that materials have been found in some devices’ male luers.

Aortic root cannulas are medical devices that are used with a type of heart and lung machine called a cardiopulmonary bypass during certain open heart surgeries to help deliver liquids or remove air from the aorta. Cardiopulmonary bypass devices take over heart and lung functions for the patient during the procedure.

In the case of the recalled Medtronic devices, loose materials have been found in the male luer part of the device’s fitting, which is used to ensure that connections remain free from leaks. These materials could potentially enter the patient’s body during surgery, leading to serious adverse health consequences, including stroke or death.

Despite the dangers posed by the affected vascular cannulas, there have been no reports of injuries.

Health care providers who have used the affected devices should continue monitoring their patients with normal follow-up procedures. The manufacturer indicates that there are no additional risks to patients who have already been treated with the devices.

However, it is recommended that facilities inventory their products to see if they have any of the affected models in their possession. A complete list of unique device identifier (UDI) numbers can be found on the FDA’s recall notice.

If affected products are found to be in a facility’s possession, providers should immediately stop using them and separate them from other materials.

Products can be returned by contacting Medtronic Customer Service at 1-800-854-3570 and pressing Option 1, then Option 4. Credits will be issued for returned products.

In addition, facilities should complete a Customer Confirmation Form to send to Medtronic via email at RS.CFQFCA@medtronic.com. The form should be filled out even if the facility does not have any of the affected devices in its possession.

U.S. customers with additional questions should contact either their Medtronic field representative or the company’s Customer Service department at 1-800-854-3570. Professionals and consumers can also report any adverse reactions or quality problems to MedWatch, the FDA’s safety information and adverse event reporting program.

Impella Heart Pump Issues

Medtronic is not the only provider of heart support systems that has faced recalls in recent years. AbioMed’s Impella heart pump has also been the subject of numerous recalls and warnings.

A 2023 recall was issued for the Impella left sided blood pump, following reports of heart ventricle perforations, which linked the device to 129 injuries and 49 deaths. Another Impella recall that year indicated that purge fluid leaks could lead to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints.

As a result of the continued Impella heart pump problems, the first known Impella heart pump lawsuit was filed earlier this year, by the widower and daughter of a woman who passed away after open-heart surgery at SSM St. Louis University Hospital in September 2022. 

The wrongful death claim asserts that the Impella 5.5 device, designed to aid heart function during recovery, was critically flawed and led to intravascular hemolysis—a severe degradation of red blood cells. The lawsuit alleges that a manufacturing defect hindered the proper release of the pump’s lead, significantly contributing to her death.

As a result, Impella heart pump recall lawyers are actively investigating cases for individuals who have received the devices and experienced any of the following injuries:

• Heart tear/perforation
• Stroke Organ failure
• Wrongful death
• Anemia
• Blood clots
• Hypertension
• Bleeding events
• Prolapsed valve
• Vascular damage
• Reduced blood flow
• Hemolysis (Red blood cell destruction)
• Other serious injury

Attorneys working on these cases offer free consultations and evaluations to assist individuals across the U.S. in determining whether they may be eligible for financial compensation or settlement benefits through an Impella heart pump lawsuit.