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Human heart with clogged arteries. 3d illustration

The U.S. Food and Drug Administration (FDA) recently announced the recall of about 142 Medtronic Rashkind Balloon Septostomy Catheters. The FDA has identified this as a Class I recall, the most serious type of recall, which indicates that the use of these devices may cause serious injuries or death.

The catheter is used to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects.

Medtronic Has Stopped Producing These Catheters

Medtronic sent an urgent medical device letter to all affected customers last September 9, 2020. In it, the company detailed the issues associated with the Rashkind Balloon Septostomy Catheters.

Before that, by August 31, 2020, Medtronic had received nine complaints involving balloon integrity and subsequent failure that involved one patient death and one patient material embolization (blood clot). Material rupture/balloon failure during a reparative procedure can result in a blood clot, balloon leak, balloon burst, inversion or stretching resulting in balloon failure, or surgical intervention.

Medtronic directed users to identify and quarantine all unused catheters affected by the recall, and to return them to Medtronic. Customers with questions could call Medtronic Customer Service at 888-283-7868.

The company stated there were no actions required for patients previously treated by the Rashkind Balloon Catheter, except that these patients should continue to be monitored following medical standards.

More recently, the FDA identified this recall as a serious Class I recall. Medtronic has stopped manufacturing and distributing these catheters due to reasons unrelated to this recall.

What is Cyanotic Heart Disease?

Cyanotic heart disease refers to a group of many different heart defects that are present at birth. Cyanosis refers to the bluish color of the skin and mucous membranes that can develop as a symptom of these defects—caused by a low blood oxygen level.

Heart defects that can cause cyanosis or cyanotic heart disease include defects of the valves that carry blood through the heart channels, abnormalities in valve development, or unusual locations of the connections between the blood vessels. Whatever may be causing the defect, the blood does not flow as it should, and the body does not receive the oxygen it needs for normal operation.

What Are Medtronic Rashkind Septostomy Balloon Catheters?

Infants that suffer from cyanotic heart disease caused by heart valve problems are usually treated via surgery to repair the defect. There are a variety of types of surgeries used to correct the problems that may be present.

The Medtronic Rashkind Balloon Septostomy Catheters are used in procedures meant to treat cyanotic heart disease. The catheters are small tubes through which surgeons thread reparative tools and solutions to address the defect.

Medtronic is recalling these catheters because of device quality issues that may lead to the catheters breaking, separating, or failing during use. If this occurs, it may cause damage to blood vessels and even death in the patient.

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