According to a recall notice from the U.S. Food and Drug Administration (FDA), and a news story from the startribune.com, Medtronic PLC has initiated a safety recall of its Rashkind Balloon Septostomy Catheters due to reports of injuries and at least one fatality. The Rashkind balloon septostomy catheters are used to create an atrial septal defect or enlarge an existing atrial septal defect in patients who have a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are a rare condition that is connected with high morbidity and mortality.
According to the news report, the catheters are being recalled due to quality issues, and the FDA classified the recall as a Class I recall, which is the most serious type of recall. The FDA issues a Class I recall when a medical device, product, or medication may cause injury or death.
The FDA stated that the quality issues centered around the Medtronic Rashkind balloon septostomy catheters might result in the catheters breaking, separating, or failing while inside the patient. If the catheter fails in any of the aforementioned ways, the affected product could cause adverse health outcomes such as vascular injury and death.
The news report asserts that Medtronic has previously stopped manufacturing and distributing the catheter. Medtronic stated that their decision to stop manufacturing the catheters was unrelated to this recall.
On September 9, 2020, the Dublin-based medical device maker distributed an urgent letter to all affected customers directing them to return the catheters to Medtronic.
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